| CTRI Number |
CTRI/2018/01/011185 [Registered on: 08/01/2018] Trial Registered Prospectively |
| Last Modified On: |
18/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Clinical bioequivalence study of Nevirapine Prolonged Release Tablets 400 mg in HIV-1 infected patients |
|
Scientific Title of Study
|
An open label, randomized, single centre two-treatment, two-sequence, two-period, crossover, multiple dose comparative oral bioavailability study of Nevirapine Prolonged Release Tablets 400 mg (Test) of Aurobindo Pharma Ltd., India and Viramune (Nevirapine) 400 mg Prolonged-Release Tablets (Reference) of Boehringer Ingelheim Pharma GmbH & Co.KG, Germany in 36 HIV-1 Infected Patients under fasting conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEV-001-15, Version 02, Dated 15.11.17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poongulali Selvamuthu |
| Designation |
Senior Medical Officer |
| Affiliation |
YRGCARE Medical Centre |
| Address |
YRGCARE Medical Centre, Voluntary Helath Services, Rajiv Gandhi Salai, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
04439106820 |
| Fax |
04422542939 |
| Email |
poongulali@yrgcare.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poongulali Selvamuthu |
| Designation |
Senior Medical Officer |
| Affiliation |
YRGCARE Medical Centre |
| Address |
YRGCARE Medical Centre, Voluntary Helath Services, Rajiv Gandhi Salai, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
04439106820 |
| Fax |
04422542939 |
| Email |
poongulali@yrgcare.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poongulali Selvamuthu |
| Designation |
Senior Medical Officer |
| Affiliation |
YRGCARE Medical Centre |
| Address |
YRGCARE Medical Centre, Voluntary Helath Services, Rajiv Gandhi Salai, Taramani, Chennai
Chennai
TAMIL NADU
600113
India |
| Phone |
04439106820 |
| Fax |
04422542939 |
| Email |
poongulali@yrgcare.org |
|
|
Source of Monetary or Material Support
|
| APL Research Center Aurobindo Pharma Limited Survey No -313, Bachupally Village,
Quthubullapur Mandal, Hyderabad -500 090, India |
|
|
Primary Sponsor
|
| Name |
APL Research Center |
| Address |
APL Research Center Aurobindo Pharma Limited Survey No -313,
Bachupally Village, Quthubullapur Mandal, Hyderabad -500 090,
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praksh H Kurmi |
Shivam Hospital |
C-4, Satyanarayan Society, Gor’s Kuva, Jashodanagar Char rasta, Maninagar (E), Ahmedabad – 380008, Gujarat, India
Ahmadabad
GUJARAT |
09925047695
079-25835831
dr_prakashkurmi@yahoo.co.in |
| Dr Poongulali Selvamuthu |
YRGaitonde Center for Aids Research and Education |
YRGaitonde Center for Aids Research and Education,
Voluntary Health Services Campus,
Room No. 01, Ground Floor,
Antiviral Treatment & Clinical Research Division,
Rajiv Gandhi Salai, Taramani, Chennai 600113
Chennai
TAMIL NADU |
04439106820
04422542939
poongulali@yrgcare.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Shivam Ethics Committee |
Approved |
| YRG Care Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HIV-1 Infected , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nevirapine Prolonged Release Tablets 400 mg
|
This study will consists of two periods and is multiple dose study. Eligible patients will be
administered with test or
reference once daily orally for 14 consecutive days in each period crossed over without washout. |
| Comparator Agent |
Viramune (Nevirapine) 400 mg Prolonged-Release Tablets
Manufactured by Boehringer Ingelheim Pharma GmbH & Co.KG, Germany. |
This study will consists of two periods and is multiple dose study. Eligible patients will be administered with test or reference once daily orally for 14 consecutive days in each period crossed over without washout. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female subject aged between 18 and 65 years of age (both inclusive) at the time of informed consent and should have BMI ≥ 18.5 to ≤ 30 kg/m2.
2.Non smokers and non alcoholics.
3.Subject with a stable Nevirapine based combination antiretroviral regimen for at least the preceding 12 weeks (or 6 weeks if switched from an antiretroviral regimen containing two nucleoside analogues and Efavirenz) that is recommended according to British HIVAssociation clinical guidelines:
a. Abacavir and lamivudine {ABC/3TC} as fixed dose combination
b. Tenofovir and emtricitabine {TDF/FTC}
c. Zidovudine and lamivudine {AZT/3TC}, OR
d. Tenofovir and lamivudine as separately prescribed components and kept constant (in combination and dosage) throughout the whole course of the study.
4.Absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, psychiatric, gastrointestinal, renal, hepatic, obstructive disorders, cholestasis, and metabolic disease.
5.Subjects with An HIV viral load < 50 copies/mL in preceding 12 months and at screening.
6.Subjects with a CD4+ Tcell count > 50 cell/mm3 in preceding 12 months and at screening.
7.Subject should be otherwise healthy as determined by general and systemic examination, medical history and have no significant abnormality in any of the laboratory parameters including ECG and Chest X-ray.
8.Subject with no history of addiction to any recreational drug or drug dependence
9.Acceptable screening laboratory values that indicate adequate baseline organ function.
10.Willingness to abstain from ingesting medications that are listed as contraindicated for Nevirapine during the whole course of the study.
11.Capable of completing patient diaries.
12.Capable and willing to come back for PK assessments and follow up.
13.Willingness to refrain from excessive physical activity during the trial.
14.Subject must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.
15.Female subject of childbearing potential should be willing to use a reliable method of birth control
16.Female subject must have a negative pregnancy test at Screening.
|
|
| ExclusionCriteria |
| Details |
1.Subject Current treatment with an HIV protease inhibitor
2.Subject had Infection with HIV2 or HIV1 group O.
3.Subject Laboratory parameters > DAIDS grade 2 Coagulation.
4.Subject Laboratory parameters > DAIDS grade 2 Total triglycerides
5.Use of concomitant medication (other than the stable background antiretroviral HIV therapy) that may interfere with the pharmacokinetics of Nevirapine and/or the background antiretroviral HIV therapy)
6.Intake of products containing St. Johns Wort from 14 days before treatment with study medication (Day 1) and not willing to abstain from it throughout the study until completion of the study
7.Subject undergone major surgery within 4 weeks of enrolment.
8.Subject had history of hypersensitivity or idiosyncratic reactions to any drug product or its excipients etc
9.History of difficulty with donating blood or difficulty in swallowing the drug or difficulty in accessibility of veins.
10.High caffeine (more than 5 cups of coffee or tea/day) consumption.
11.Subject diagnosed to be Hepatitis B (HBs Ag) or Hepatitis C (HCV) virus reactive/positive.
12.Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
13.Female subject who is pregnant or currently breast-feeding.
14.Subject donated blood ≥ 350 mL within 90 days of screening.
15.Subject participation in another clinical trial within the preceding 90 days of study starts.
16.Received pharmacological agents known to significantly induce or inhibit drug metabolizing enzymes within 14 days of the start of the study
17.Subject with history of arterial thrombosis or deep vein thrombosis within the past year.
18.Patients on Tuberculosis treatment with Rifampicin
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
AUC0-tau: Area under the plasma concentration –
time curve over the steadystate dosing interval.
Cmax-ss: Maximum concentration over the
steady state dosing interval.
Ctau: Concentration at the end of dosing interval |
Predose sample will be collected within 5 minutes prior to dosing on Day 1, 12, 13 & 14 in Period I and
on Day 15, 26, 27 and 28 in Period II. On Day 14
and Day 28, post dose samples will be
collected at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00,
7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00 and
24.00 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Css-avg,Percentage fluctuation, Tmax ss and
Cmin-ss, Safety and tolerability |
Predose will be collected within 5 minutes prior
to dosing on Day 1, 12, 13 & 14 in Period I and on Day 15, 26, 27 and 28 in Period II. On Day 14 and Day 28, post dose samples will be
collected at 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 12.00, 16.00, 20.00 and 24.00 hours |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
20/01/2018 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open label,
randomized, single centre two-treatment, two-sequence, two-period, crossover,
multiple dose comparative oral bioavailability study of Nevirapine Prolonged
Release Tablets 400 mg (Test) of Aurobindo Pharma Ltd., India and Viramune
(Nevirapine) 400 mg Prolonged-Release Tablets (Reference) of Boehringer
Ingelheim Pharma GmbH & Co.KG, Germany in 36 HIV-1 Infected Patients under
fasting conditions. |