Single dose Fed oral bioequivalence study of Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg of Mylan Laboratories Limited, India with Reference product (R= R1 + R2) R1: Truvada® (emtricitabine and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg Manufactured for: Gilead Sciences Inc, Foster City, CA 94404, Made in Germany and R2: Levora® 0.15/30-28 (Levonorgestrel and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg Distributed by: Mayne Pharma Greenville, NC 27834 in healthy adult female subjects.â€
Trial Acronym
N/A
Secondary IDs if Any
Secondary ID
Identifier
TRLV-TBZ-1010, Version:01, Dated: 09/01/ 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Nikhil Kumar Kursam M B B S M D
Designation
Principal Investigator
Affiliation
Aizant Drug Research Solutions Pvt Ltd
Address
Aizant Drug Research Solutions Pvt Ltd,
Survey No 172 and 173, Apparel Park Road,
Dulapally Village, Dundigal Gandimaisamma Mandal
Medchal TELANGANA 500100 India
Phone
914023792190
Fax
914023792223
Email
nikhil.kursam@aizant.com
Details of Contact Person Scientific Query
Name
Dr Ramana Reddy Nalla MBBS
Designation
Principal Investigator
Affiliation
Aizant Drug Research Solutions Pvt Ltd
Address
Aizant Drug Research Solutions Pvt Ltd,
Survey No 172 and 173, Apparel Park Road,
Dulapally Village, Dundigal Gandimaisamma Mandal
TELANGANA 500100 India
Phone
914023792190
Fax
914023792223
Email
ramana.nalla@aizant.com
Details of Contact Person Public Query
Name
Dr Ramana Reddy Nalla MBBS
Designation
Principal Investigator
Affiliation
Aizant Drug Research Solutions Pvt Ltd
Address
Aizant Drug Research Solutions Pvt Ltd,
Survey No 172 and 173, Apparel Park Road,
Dulapally Village, Dundigal Gandimaisamma Mandal
TELANGANA 500100 India
Phone
914023792190
Fax
914023792223
Email
ramana.nalla@aizant.com
Source of Monetary or Material Support
Mylan Laboratories Limited (A Viatris Company), Clinical Research Centre, Saradhi Chambers, Plot No A-4, Beside Poulomi Hospital, Rukminipuri, Dr A S Rao Nagar, Hyderabad – 500062
Primary Sponsor
Name
Mylan Laboratories Limited (A Viatris Company)
Address
Clinical Research Centre, Saradhi Chambers, Plot No A-4, Beside Poulomi
Hospital, Rukminipuri, Dr A S Rao Nagar, Hyderabad – 500062
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Nikhil Kumar Kursam M B B S MD
Aizant Drug Research Solutions Pvt Ltd
Survey No 172 and 173, Apparel Park Road,
Dulapally Village, Dundigal Gandimaisamma Mandal Medchal TELANGANA
This protocol describes an open labelled, single-dose, randomized, balanced, two-period, two-sequence, two-treatment, two-way, crossover study to investigate the bioequivalence in healthy adult female subjects. There will be at least 14 days between dosing times for the treatment periods.
This protocol describes an open labelled, single-dose, randomized, balanced, two-period, two-sequence, two-treatment, two-way, crossover study to investigate the bioequivalence in healthy adult female subjects. There will be at least 14 days between dosing times for the treatment periods.
This protocol describes an open labelled, single-dose, randomized, balanced, two-period, two-sequence, two-treatment, two-way, crossover study to investigate the bioequivalence in healthy adult female subjects. There will be at least 14 days between dosing times for the treatment periods.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Female
Details
Subjects must fulfill all of the following criteria to be considered for inclusion into this study:
1. Normal healthy adult female subjects, age between 18 to 45 years.
2. Body mass index of  18.5 kg/m2
and ï‚£ 30.0 kg/m2
and weight  50.00 kg.
3. Healthy according to the laboratory results and physical examination, performed
within 21 days prior to the commencement of the dosing in Period-1.
4. Subject whose clinical laboratory values are within normal limits or clinically
insignificant as determined by physician or principal investigator to be of no clinical
significance.
5. Have normal ECG, Chest X-ray and vital signs.
6. Non-smoker and Non-alcoholic.
7. Willing to not to participate in clinical research study or blood donations till 90 days
after the study completion.
8. Subject able to communicate effectively and provide written informed consent.
9. Subject willing to adhere to protocol requirements as evidenced by written informed
consent approved by an Independent Ethics Committee (IEC).
10. If study subject is a female and is of child bearing potential practicing an acceptable
method of birth control for the duration of the study as judged by the investigator(s),
such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence:
(Or)
is postmenopausal for at least 1 year
(Or)
is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
has been performed on the study subject).
ExclusionCriteria
Details
Subject candidates must not be enrolled in the study if they meet any of the following
criteria:
1. Any history of allergy or hypersensitivity to Emtricitabine, Tenofovir Disoproxil
Fumarate, Levonorgestrel and Ethinyl Estradiol or other related drugs.
2. Positive test result for hepatitis B surface antigen (HBs Ag), hepatitis C virus antibody
(HCV Ab) or HIV-1 antibody or HIV Type 2 (HIV-2) antibody (HIV Ab).
3. The study drug is contraindicated for medical reasons.
4. Amenorrhea or irregular menstrual periods (defined unable to predict within 7 days)
during past 6 months for females.
5. Any history or presence of significant cardiovascular, pulmonary, hepatic, renal,
gastrointestinal, endocrine, dermatological, neurological, psychiatric diseases or
disorders.
6. History or presence of drug abuse in the past one year.
7. Difficulty in swallowing tablets.
8. Any history of difficulty in donating blood.
9. Had clinically significant abnormal values of laboratory parameters.
10. History of pathologic fracture or other risk factors for osteoporosis or bone loss.
11. Subjects with Creatinine clearance <50ml/min
12. any past medical history or family history of thrombotic or thromboembolic disorder
13. history suggests an inherited or acquired hypercoagulopathy
14. history of cholestasis,pancreatitis and other gall bladder disorders.
15. History or presence of migraine headache with or without aura.
16. History of amenorrhoea, oligomenorrhoea and irregular menstruation.
17. History of Hereditary Angioedema and a history of chloasma gravidarum.
18. Subject having Modified Patient Health Questionnaire (MPHQ) -12 questionnaires >4
in each period check-in.
19. Blood pressure is < 100/60 and > 129/79 millimeters of mercury (Systolic blood
pressure/ Diastolic blood pressure).
20. Pulse rate less than 60 beats / minute and more than 100 beats / minute.
21. Use of any prescription or over the counter (OTC) medications other than hormonal
contraceptive or hormone replacement therapy within the 14 days prior to the initial
administration of study medication.
22. Use of depot injection or implant of any drug other than hormonal contraceptive or
hormone replacement therapy within 3 months prior to initial administration of study
medication.
23. Use of any medication, herbal supplement, or vitamin known to induce or inhibit
hepatic enzyme activity within 28 days prior to the initial administration of study
medication.
24. Any clinically significant illness during 3 months before screening.
25. Participation in a drug research study/donation of blood within past 90 days.
26. Female subject who is currently breast feeding or a female study subject who is
pregnant or who is likely to become pregnant during the study.
27. Female subject demonstrating positive for pregnancy test (performed at the time of
each period check-in).
28. Consideration by the investigator, for any reason that the subject is an unsuitable candidate to receive study drug.
Subject positive for urine alcohol test, urine screen for drugs of abuse [Cannabinoids (Marijuana / Tetra Hydro Cannabinoids-THC), Cocaine, Opiates (morphine), Amphetamine, Barbiturates and Benzodiazepines] and serum pregnancy test (for female subjects only) at the time of each period check-in will be excluded from the study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
The objective of this study is to investigate the bioequivalence of Test product (T) Emtricitabine,
Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg of Mylan Laboratories Limited, India with Reference product (R equal to R1 + R2) R1- Truvada® (emtricitabine and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg Manufactured for- Gilead Sciences Inc, Foster City, CA 94404, Made in Germany and R2- Levora® 0.15/30-28 (Levonorgestrel and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg Distributed by- Mayne Pharma Greenville, NC 27834 in healthy adult female subjects
In each study period, Six milliliter (1 × 6 mL) blood samples (23) will be
collected in K2EDTA Vacutainers at pre-dose (0.00) and the following times
after dosing 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00,
5.50, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 and 72.00 hours.
Secondary Outcome
Outcome
TimePoints
to monitor the adverse events & to ensure the safety of the subjects under fed conditions
45 days clinical schedule
Target Sample Size
Total Sample Size="80" Sample Size from India="80" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
This protocol
describes an open labelled, single-dose, randomized, balanced, two-period,
two-sequence, two-treatment, two-way, crossover study to investigate the
bioequivalence of Test product (T) Emtricitabine, Tenofovir Disoproxil
Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15
mg/0.03 mg of Mylan Laboratories Limited, India with Reference product (R= R1 +
R2) R1: Truvada®
(emtricitabine
and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg Manufactured for:
Gilead Sciences Inc, Foster City, CA 94404, Made in Germany and R2: Levora® 0.15/30-28 (Levonorgestrel
and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg Distributed by: Mayne
Pharma Greenville, NC 27834.
Single dose fed
pharmacokinetics will be characterized in Fifty-four (54) healthy adult female
subjects following administration of a single oral dose of either test product
(T) or reference product (R= R1 + R2) as per randomization schedule.
In each study
period, Six milliliter (1 × 6 mL) blood samples (23) will be collected in K2EDTA Vacutainers
at pre-dose (0.00) and the following times after dosing 0.25, 0.50, 0.75, 1.00,
1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 8.00, 10.00, 12.00,
16.00, 24.00, 36.00, 48.00 and 72.00 hours. The Collected blood samples will be
placed in an ice bath and centrifuged under refrigeration as soon as possible.
Three aliquots (aliquot 1 of 3, aliquot 2 of 3 and aliquot 3 of 3) of plasma
will be extracted and stored in suitably labeled tubes at -70°C or colder with
an acceptable operating range within - 55°C to -90°C at the clinical site until
transferred on dry ice to analytical site. For the determination of the
pharmacokinetic disposition of the formulations, there will be a total of 46
(23 in each period) blood samples involving a total of 276 mL of blood
collected for pharmacokinetic analysis from each subject in the study. There
will be at least 14 days gap between dosing times for the treatment periods. The
bioequivalence of Test product (T) Emtricitabine, Tenofovir Disoproxil Fumarate,
Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg of
Mylan Laboratories Limited, India with Reference product (R= R1 + R2) R1:
Truvada®
(emtricitabine
and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg Manufactured for:
Gilead Sciences Inc, Foster City, CA 94404, Made in Germany and R2: Levora® 0.15/30-28
(Levonorgestrel and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg Distributed
by: Mayne Pharma Greenville, NC 27834 will be assessed by a statistical
comparison of various pharmacokinetic parameters derived from the plasma
concentrationtime curves of the drug.
OBJECTIVES
The objective of this study is to investigate the bioequivalence of Test product (T) Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg of Mylan Laboratories Limited, India with Reference product (R= R1 +R2) R1: Truvada® (emtricitabine and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg Manufactured for: Gilead Sciences Inc, Foster City, CA 94404, Made in Germany and R2: Levora® 0.15/30-28 (Levonorgestrel and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg Distributed by: Mayne Pharma Greenville, NC 27834 in healthy adult female subjects and monitor the adverse events and to ensure the safety of the subjects under fed conditions.
STUDY DRUG
Investigational Drug: Test product (T): Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg, Manufactured by: Mylan Laboratories Limited, India.
Reference product (R= R1+R2): (R1): Truvada® (emtricitabine and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg, Manufactured for: Gilead Sciences Inc, Foster City, CA 94404, Made in Germany. (R2): Levora® 0.15/30-28 (Levonorgestrel and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg, Distributed by: Mayne Pharma Greenville, NC 27834. Manufactured by: Patheon, Inc., Mississauga, Ontario L5N 7K9, CANADA.
STUDY CONDUCT
This is an open labelled, single-dose, randomized, balanced, two-period, two-sequence, two-treatment, two-way, crossover study to investigate the bioequivalence of Test product (T) Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg of Mylan Laboratories limited, India with Reference product (R=R1 + R2) R1: Truvada® (emtricitabine and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg Manufactured for: Gilead Sciences Inc, Foster City, CA 94404, Made in Germany and R2: Levora® 0.15/30-28 (Levonorgestrel and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg Distributed by: Mayne Pharma Greenville, NC 27834 in healthy adult female subjects. Single-dose fed pharmacokinetics will be characterized in Fifty-four (54) healthy adult female subjects following administration of a single oral dose of either test product or reference product will be administered under fed conditions. Subjects will be housed in the clinical facility for at least 10.50 hours prior to dosing of each period and until at least 72.00 hours after investigational drug administration. Blood samples will be collected prior to dosing and for 72.00 hours after each dosing. There will be at least 14 days between dosing times for the treatment periods. Individual subjects should be dosed at approximately the same time of day in each dosing period. It is the sponsor’s intent to complete all subjects simultaneously. Thus, it is anticipated that all subjects will be completed in a single cohort within approximately 18 days following the initiation of dosing. If multiple cohorts are necessary to enroll the required number of subjects, no two cohorts can be dosed on the same day.
Screening Procedures
Each prospective subject must agree to participate in screening procedures by signing the most recent Institutional Review Board/Independent Ethics Committee approved Informed Consent Document (ICD) before any screening procedure is initiated. The Principal Investigator or Medical Sub-Investigator will review the inclusion and exclusion criteria to confirm eligibility of each subject prior to enrollment. Each subject will undergo a screening procedure for health assessment, which consists of a complete medical history, physical examination with vital signs, clinical laboratory evaluations, 12-lead ECG and Chest X-ray PA view. The physical examination findings, ECG, serum pregnancy test and the laboratory tests can be considered as valid for maximum of 21 days prior to the dosing (drug administration) in first period of the study. Chest X-ray PA view will be taken within 6 months prior to dosing (drug administration) of period-1.
The physician in charge will assess abnormal values to determine if it is clinically significant.
Clinical/Laboratory Diagnostic Tests:
Hematology: Red blood cell count, White blood cell count, Differential white blood cell count (Neutrophils%, Lymphocytes%, Eosinophils%, Monocytes % and Basophils %), Hemoglobin estimation, Platelet count, Blood grouping and Rh typing. Prothrombin time (PT), activated partial thromboplastin time (aPTT) and International normalized ratio (INR).
Biochemistry: Serum creatinine, Blood urea, SGOT (AST), SGPT (ALT), Serum alkaline phosphatase (ALP), Total bilirubin, Blood sugar / Plasma Glucose (Random) and Serum electrolytes (Sodium, Potassium and Chloride)
Serology: HIV (1 & 2) antibodies, Hbs Ag (Hepatitis B surface antigen) and HCV antibodies.
Urine analysis: Color, Appearance/Transparency, pH, Specific gravity, Glucose, Ketones, Bilirubin, Blood, Leucocytes, Proteins, Nitrite, Urobilinogen and Urine microscopic examination (Pus Cells, Red Blood Cells, Epithelial Cells, Casts and Crystals).
Pregnancy test for females: Serum β-HCG pregnancy test
Enough subjects from the general population will be available in the clinic for Period-1 dosing in order to dose the required number of subjects. Subjects will be housed 11.00 hours prior to dosing until at least 72.00 hours after dosing.
Bioanalytical Method
A validated assay method will be employed for the analysis of Emtricitabine, tenofovir, levonorgestrel and ethinyl estradiolin plasma samples. Full validation of the method, including precision, accuracy and reproducibility will be included in the final report, along with a statement regarding the stability of frozen samples.
Repeat analysis and ISR will be performed as per respective inhouse SOPs of designated bioanalytical facility. Specific details of recovery, precision and accuracy, specificity, selectivity and sensitivity of the assay will be included in the final report.
If clinical part conducts in group, the bioanalysis will be initiated after completion of each group, but plasma concentration data will be released to PK/Stats after completion of all subjects in study.
Pharmacokinetic Parameter Determination
All concentration values below the lower limit of quantification (BLOQ) will be set to zero, concentration obtained as 0, <0. No Peak will be reported as Zero for all pharmacokinetic and statistical calculations. Any missing samples will be reported as ‘M’ and will not be included for pharmacokinetic and statistical analysis.
The following pharmacokinetic parameters will be computed by using Phoenix® WinNonlin® version 8.0 or higher version for Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol through non compartmental method.
Note:
1: For all the above computations, actual time points of the sample collection will be used in case of sample collection deviations. 2: For an acceptable Kel value, r should not be less than 0.8944 (or r2 not less than 0.80). If r is less than 0.8944, then Kel is set missing. 3: If the pre-dose value is greater than 5% of Cmax, in any period then that subject/period data will be dropped from pharmacokinetics and statistical analysis. 4: If any subject experiences emesis at or within two times the median Tmax (2 × 3.25 hours = 6.5 hours) following the drug administration in each study period, such subject data will be analyzed however data of the subject will not be included in pharmacokinetic and statistical analysis.
Statistical Analysis of the Pharmacokinetic Parameters
Statistical analysis will be performed on the data obtained from the subjects who completed the study as per IEC approved protocol using SAS version 9.4 or higher version. Descriptive statistics of all the pharmacokinetic parameters will be computed and reported for Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol.
The summary statistics (for relevant pharmacokinetic parameters) will be computed and reported for both test and reference products of Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol.
The ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf of Emtricitabine, tenofovir and ethinyl estradiol and Cmax & AUC0-72 of Levonorgestrel will be subjected to Analysis of Variance (ANOVA). ANOVA model will include Sequence, Formulation, Period and Subject (Sequence) as fixed effects.
Sequence effect will be tested using Subject (Sequence) as an error term.
An F-test will be performed to determine the statistical significance of the effects involved in the model at a significance level of 5% (alpha =0.05).
All the period, Treatment and sequence effects will be tested at 5% Level of Significance.
Two one-sided test for bioequivalence and 90% confidence intervals for the ratio of least squares mean between drug formulations will be calculated, for ln-transformed data of Cmax, AUC0-t and AUC0-inf of Emtricitabine, tenofovir and ethinyl estradiol and Cmax & AUC0-72 of Levonorgestrel.
The power of a test to detect 20% difference between test and reference products will be computed and reported for Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol.
Ratio of least squares means of test and reference products will be computed for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf.
Ratio analysis will be reported for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf of Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol.
Intra-Subject variability will be computed for ln-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf of Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol.
BE criteria
Emtricitabine, tenofovir, levonorgestrel and ethinyl estradiol: The 90% geometric confidence intervals of the ratio (T/R or A/B) of least-squares means from the ANOVA of the natural log transformed Cmax, AUC0-t and AUC0-inf should be within 80.00% to 125.00% for emtricitabine, tenofovir and ethinyl estradiol.
Levonorgestrel: The 90% geometric confidence intervals of the ratio (T/R or A/B) of least squares means from the ANOVA of the natural log transformed Cmax and AUC0-72 should be within 80.00% to 125.00% for levonorgestrel.
Determination of biologically implausible (pharmacokinetic) outliers will be based on the observed results (concentration data; such as no detectable plasma concentration following the administration of drug) which are determined to be discordant with the rest of the subjects. Clinical and bioanalytical circumstances will be examined in an attempt to provide insight into the apparent anomalous results.
It is the sponsor’s intent to complete this study in one cohort. In the event that separate enrollments are necessary to complete the intended number of subjects, appropriate adjustments may be made to the statistical model to reflect the multi-cohort nature of the study.
a. Additional cohorts will be recruited and dosed under the following conditions:
i. Recruiting for additional enrollment(s) begin before the end of the final period of the previous enrollment; ii. Subjects are recruited from the same population, under the same protocol requirements; iii. dosing of additional cohorts began as soon as practical after their recruitment; and iv. no two cohorts are dosed on the same day.
b. Appropriate adjustments will be made to the statistical model to reflect the multi-cohort nature of the study if:
i. the number of cohorts is less than or equal to 3; and ii. there are at least 6 subjects in each cohort
APPENDIX VI: STUDY CONDUCT INFORMATION
The clinical research organization conducting this study on behalf of Mylan Laboratories Ltd., India is required to complete this sheet and forward to Mylan prior to the enrollment of any subjects into the study. Any updates throughout the study conduct period must be reported on this sheet.
Protocol Number: TRVL-TBZ-1010
Protocol Title: Single dose Fed oral bioequivalence study of Emtricitabine, Tenofovir Disoproxil Fumarate, Levonorgestrel and Ethinyl Estradiol Tablets 200 mg/300 mg/0.15 mg/0.03 mg of Mylan Laboratories Limited, India with Reference product (R= R1 + R2) R1: Truvada® (emtricitabine and tenofovir disoproxil fumarate) tablets 200 mg / 300 mg Manufactured for: Gilead Sciences Inc, Foster City, CA 94404, Made in Germany and R2: Levora® 0.15/30-28 (Levonorgestrel and Ethinylestradiol Tablets USP), 0.15 mg /0.03 mg Distributed by: Mayne Pharma Greenville, NC 27834 in healthy adult female subjects.
Principal Investigator:(please attach curriculum vitae when return to Mylan)
Dr. Nikhil Kumar Kursam, M.B.B.S, M.D., Aizant Drug Research Solutions Pvt. Ltd., Survey No.: 172 &173, Apparel Park Road, Dulapally Village, Dundigal Gandimaisamma Mandal, MedchalMalkhajgiri District - 500100, Telangana, India. Phone No.: +91 40 23792190/91/92, Fax No.: +91 40 23792223 Address of Principal Investigator +91 40 23792190/91/92 Phone Number of Principal Investigator
Clinical Research Facility: Clinical Pharmacology Department, Name Clinical Development Division, Aizant Drug Research Solutions Pvt. Ltd., Survey No.: 172 &173, Apparel Park Road, Dulapally Village, Dundigal Gandimaisamma Mandal, Medchal-Malkhajgiri District - 500100, Telangana, India. Phone No.: +91 40 23792190/91/92, Fax No.: +91 40 23792223
Stastical Investigator: Mr. Udaya Kumar Konda Pharmacokinetic & Statistical analysis Aizant Drug Research Solutions Pvt. Ltd., Survey No.: 172 &173, Apparel Park Road, Dulapally Village, Dundigal Gandimaisamma Mandal, Medchal-Malkhajgiri District - 500100, Telangana, India. Phone No.: +91 40 23792190/91/92, Fax No.: +91 40 23792223 e-mail ID: udaya.konda@aizant.com
Randomization Facility: Pharmacokinetic & Statistical analysis Aizant Drug Research Solutions Pvt. Ltd., Survey No.: 172 &173, Apparel Park Road, Dulapally Village, Dundigal Gandimaisamma Mandal, Medchal-Malkhajgiri District - 500100, Telangana, India. Phone No.: +91 40 23792190/91/92, Fax No.: +91 40 23792223 e-mail ID: udaya.konda@aizant.com
Clinical data management and CDISC Facility: Inductive Quotient Analytics India private Limited. 6 th Floor, Krishe Sapphire Metro Station Durgamma, Cheruvu, Sri Sai Nagar, Madhapur, Hyderabad, Telangana 500081 Phone 040-69067400; +91 91541 98743; 91 810625012
Clinical Laboratory Facility-1:(attach separate sheet for each facility, if necessary)
Aizant Drug Research Solutions Pvt. Ltd.,Diagnostics Department Name
Clinical Development Division, Aizant Drug Research Solutions Pvt. Ltd., Survey No.: 172 &173, Apparel Park Road, Dulapally Village, Dundigal Gandimaisamma Mandal, Medchal-Malkhajgiri District-500100 Telangana,India Address of Clinical Laboratory Facility +91 40 23792190/91/92 Phone Number of Clinical Laboratory Facility
Clinical Laboratory Facility-2:(attach separate sheet for each facility, if necessary)
Lucid Medical Diagnostics Pvt. Ltd., Name
Plot No.: 203, Vasavi Nagar, Karkhana. Secunderabad, Telangana, India-500015 Address of Clinical Laboratory Facility +91 40 44114444 Phone Number of Clinical Laboratory Facility
Clinical Laboratory Facility-3: CENTROMED LABS PVT LTD., House No.: 11-20/7/A/2 to 5, Plot No. 8, 3rd Floor, Chinnabalappa Complex, Near Moosarambagh Metro Station, Pillar No. A1478, Saleem Nagar Colony, Malakpet, Hyderabad-500036, India. Tel. 040-35162091, 92, 93, 94.
