CTRI/2024/07/070445 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On:
09/07/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Other
Public Title of Study
It is a phase-I,open-label,non-randomized,multiple-dose,two-treatment,single sequence,drug drug interaction study to assess pharmacokinetics,pharmacodynamice,safety and tolerability study in healthy adult human female subjects under fasting condition.
Scientific Title of Study
A PHASE - 1, OPEN-LABEL, NON-RANDOMIZED, MULTIPLE-DOSE, TWO-TREATMENT, SINGLE SEQUENCE, DRUG-DRUG INTERACTION STUDY TO ASSESS PHARMACOKINETICS (PK), PHARMACODYNAMICS (PD), SAFETY, AND TOLERABILITY OF AN ORAL CONTRACEPTIVE CONTAINING ETHINYL ESTRADIOL (EE) 0.03 MG AND LEVONORGESTREL (LNG) 0.15 MG TABLET WHEN ADMINISTERED ALONE AND IN COMBINATION WITH HRF-10071 TABLET 120 MG IN HEALTHY, ADULT, HUMAN FEMALE SUBJECTS UNDER FASTING CONDITION.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
HCR/I/HRF10071-OCP/12/2023, Ver No. 1.0, Date: 03 Jan 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dwarkesh Oswal
Designation
Sr. Manager
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department of Clinical Research, Room No. NA, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad GUJARAT 382481 India
Phone
07940202281
Fax
07940202021
Email
dwarkeshroswal@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Department of Clinical Research, Room No. NA, Plot No. 38, Survey no. 388,Near Silver Oak Club, S. G. Highway, Gota
Ahmadabad GUJARAT 382481 India
Phone
07940202214
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Shubhadeep Sinha
Designation
Sr. Vice - President and Head
Affiliation
Hetero Labs Limited
Address
Department of Clinical Development and Medical Affairs, Room No. NA, 7-2- A2, Industrial Estates, Sanathnagar, Hyderabad, TELANGANA, 500018, India
Lambda House, Plot No. 38, Survey No. 388,
Near Silver Oak Club S. G. Highway, Gota, Ahmedabad -382481
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Dwarkesh Oswal
Lambda Therapeutic Research Ltd
Department of Clinical Research, Room No .NA,Lambda house, Plot No. 38, Survey no.388,Near Silver Oak Club, S. G. Highway, Gota Ahmadabad GUJARAT
07940202281
dwarkeshroswal@lambda-cro.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Riddhi Medical nursing Home IEC
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy
Intervention / Comparator Agent
Type
Name
Details
Intervention
Ethinyl Estradiol and Levonorgestrel
Dose: 0.03mg and 0.15mg,Duration and frequency :Each cycle consists of 21 days on medication and a 7-day interval without medication(three weeks on, one week off).
Comparator Agent
HRF-10071Tablet +Ethinyl Estradiol and Levonorgestrel
Dose: 120 mg + 0.03mg and 0.15mg,Duration and frequency :Each cycle consists of 21 days on medication and a 7-day interval without medication(three weeks on, one week off).
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Female
Details
a) Non-smoking, nonalcoholic, healthy adult human female participants between 18 to 45 years of age (both inclusive).
b) Having a Body Mass Index (BMI) between 18.5 and 30.0 (both inclusive), calculated as weight in kg / height in meter2 and weight not less than 50.00 Kg.
c) Not having any significant disease in medical history or clinically significant abnormal findings during screening, clinical examination, Gynecological examination (including pelvic examination and routine breast examination), laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
d) Able to understand and comply with the study procedures, in the opinion of the principal investigator.
e) Literate and able to give voluntary written informed consent for participation in the trial.
f) Pap smear and USG Pelvic should be clinically acceptable.
g) Serum Estradiol level should be clinically acceptable.
a) Surgically sterilized (bilateral tubal ligation, or hysterectomy has been performed on the participant) at least 6 months prior to study participation
OR
If of child bearing potential is willing to use a suitable and effective double barrier contraceptive method (abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam) or non-hormonal intra uterine device during the study and for 14 days after last dose.
and
Serum Pregnancy test at screening and prior to check-in of Period-I must be negative
ExclusionCriteria
Details
a) Known hypersensitivity or idiosyncratic reaction to Ethinyl Estradiol and Levonorgestrel or normally used medicines such as anti-histamines, NSAIDs or any of the excipients or related drug.
b) History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
c) Ingestion of a medicine (any prescribed medications or OTC medications, herbal products including traditional herbal remedies (e.g., Ayurveda, Unani, Traditional Chinese medicines St. John’s wort etc.), and homeopathic products, CYP inducers or inhibitors) at any time within 30 days prior to first IMP administration of Period-I and any vaccine (including COVID-19 vaccine) from 30 days prior to first dosing of period-I. In any such case participant selection will be at the discretion of the Principal Investigator.
d) Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
e) Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scans.
f) consumption of alcohol or alcoholic products within 48 hours prior to first IMP administration.
g) Smokers, or who have smoked within last six months prior to start of the study
h) History past or presence suggestive of gastric and/or duodenal ulceration.
i) History past or presence suggestive of thyroid disease, adrenal dysfunction, organic intracranial lesion.
j) The presence of clinically significant abnormal laboratory values during screening.
k) History or presence of seizure or psychiatric disorders.
l) A history of difficulty in donating blood.
m) History past or presence suggestive of cancer.
n) Difficulty in swallowing tablet/capsule.
o) Donation of blood (1 unit or 350 mL) within a period of 90 days prior to the first dose of study medication.
p) Receipt of an investigational medicinal product or participation in a drug research study within a period of 90 days prior to the first dose of study medication
If investigational medicinal product is received within 90 days where there is no blood loss except safety lab testing, participant can be included considering 10 half-lives duration of investigational medicinal product received.
q) A positive hepatitis screen including hepatitis B surface antigen and/or HCV antibodies.
r) A positive test result for HIV (1 and/or 2) antibody
t) Any Grade 2 to 4 laboratory abnormality as per CTCAE grading at Screening, with the exception of lipid abnormalities (e.g., total cholesterol, triglycerides) and ALT/AST (described above), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single screening period to determine eligibility.
u) Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction, sinoatrial pauses, bundle branch block, or conduction abnormality) which, in the opinion of the investigator will interfere with the safety for the individual participant.
v) Consumption of Grapefruits or Grapefruit products within 72 hours prior to first IMP administration.
w) An unusual diet, for whatever reason (for example, fasting, high potassium or low-sodium), for four weeks prior to first IMP administration. In any such case participant selection will be at the discretion of the Principal Investigator.
x) History or presence of significant easy bruising or bleeding
y) History or presence of significant recent trauma.
z) History of thromboembolic disease.
aa) Nursing mothers
Method of Generating Random Sequence
Other
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Ct,ss, Cmax,ss, AUC0-t,ss
0.000, 0.250, 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, 7.000, 8.000, 10.000, 12.000 and 24.000, 48.000 and 72.000
Secondary Outcome
Outcome
TimePoints
Tmax,ss, t1/2
0.000, 0.250, 0.500, 1.000, 1.500, 2.000, 2.500, 3.000, 4.000, 5.000, 6.000, 7.000, 8.000, 10.000, 12.000 and 24.000, 48.000 and 72.000
Target Sample Size
Total Sample Size="25" Sample Size from India="25" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
24/07/2024
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="1" Days="2"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a phase-I, open-label, non-randomized, multiple-dose, two treatment, single sequence, drug-drug interaction study to assess pharmacokinetics (pk), pharmacodynamics (pd), safety, and tolerability which will be conducted in normal healthy adult female volunteers under fasting condition.