| CTRI Number |
CTRI/2015/02/005493 [Registered on: 03/02/2015] Trial Registered Prospectively |
| Last Modified On: |
17/06/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Bioequivalence study comparing Nevirapine Prolonged Release 400 mg tablets (Mylan Laboratories Limited) to reference drug Viramune Prolonged-Release Tablets 400 mg under fasting conditions in adult HIV-I Infected Patients stabilized on Nevirapine |
|
Scientific Title of Study
|
An Open-Label, Randomized, Two Period, Two-Treatment, Two Sequence, Steady-State, Crossover, Multicentre, Multiple Dose, Bioequivalence study of Nevirapine Prolonged Release 400 mg tablets of Mylan Laboratories Limited, India and ‘VIRAMUNE’ (Nevirapine) Prolonged-Release Tablets 400 mg of Boehringer Ingelheim International GmbH in HIV-I Infected Patients Under Fasting Conditions |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRL101425, Version 1.0 dated 24 Oct 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charu Gautam |
| Designation |
Associate VP – Global Clinical Operation |
| Affiliation |
Cliantha Research Limited |
| Address |
Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad,
Gujarat
India Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad,
Gujarat
India Ahmadabad GUJARAT 380054 India |
| Phone |
07966135655 |
| Fax |
07966135641 |
| Email |
cgautam@clianthatrials.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chirag Shah |
| Designation |
Head- Clinical Trials |
| Affiliation |
Cliantha Research Limited |
| Address |
Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad,
Gujarat
India Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad,
Gujarat
India Ahmadabad GUJARAT 380054 India |
| Phone |
07966135631 |
| Fax |
07966135641 |
| Email |
cshah@clianthatrials.com |
|
Details of Contact Person Public Query
|
| Name |
Mr Kunal Sehra |
| Designation |
Senior Project Manager- Clinical Trials |
| Affiliation |
Cliantha Research Limited |
| Address |
Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad,
Gujarat
India Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad,
Gujarat
India Ahmadabad GUJARAT 380054 India |
| Phone |
07966135661 |
| Fax |
07966135641 |
| Email |
ksehra@clianthatrials.com |
|
|
Source of Monetary or Material Support
|
| MYLAN LABORATORIES LIMITED |
|
|
Primary Sponsor
|
| Name |
MYLAN LABORATORIES LIMITED |
| Address |
Clinical Research Centre,
Saradhi Chambers, Plot No. 4-A,
Beside Poulomi Hospital, Rukminipuri,
Dr. A. S. Rao Nagar, Hyderabad 500062 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Cliantha Research India Limited |
Sigma-1 Corporate, Off S.G.Highway, Bodakdev, Ahmedabad,
Gujarat
India
380054 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr John Thomas Ramapuram |
Kasturba Medical College Hospital |
Department of General Medicine-II, 1st floor, Attavar, Mangalore-575001, Karnataka, India Bangalore KARNATAKA |
08242425092
john@ramapuram.net |
| Dr Keyur Shah |
Medilink Hospital |
Department of Medicine, 1st Floor, Nr.Shyamal Cross Road, 132.ft ring Road,Satellite, Ahmedabad Ahmadabad GUJARAT |
07926743051 07926743051 drkeyurshah@yahoo.com |
| DrSrinivasa M |
Mysore Medical College |
Department of General Medicine, Administrative Block, Irwin Road, Mysore-570001, Karnataka, India Mysore KARNATAKA |
08212420142
drsrinivasam@gmail.com |
| Dr Urvashi Bhatara |
Sapthagiri Institute of Medical Sciences and Research Center |
Department of OBG, Sapthagiri Clintrac, Ground floor,
# 15, Chikkasandra, Hesaraghatta Main Road, Bangalore Bangalore KARNATAKA |
9448696741
urvashibhatara@gmail.com |
| DrMNLakshmikanth Reddy |
Surakshaka Diabetic Centre (P) Ltd |
Department of General Medicine, OPD-I, Ground floor, MIG – 218, KPHB Main Road, Kukatpally, Hyderabad – 500072, India Hyderabad ANDHRA PRADESH |
04040061930
mnlkreddy@gmail.com |
| Dr Alap Mehta |
Unique Hospital |
Department of Medicine, Ground Floor, Opp.Kiran Motor, Nr.Canal, Civil Hospital char Rasta-Sosyo Circle lane, Off.ring road, Surat Surat GUJARAT |
9925809158
dralapmehta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee , Unique Hospital |
Approved |
| Institutional Ethics Committee,Mysore Medical College |
Approved |
| Manipal University Ethics Committee |
Approved |
| Medilink Ethics Committee |
Approved |
| Sapthagiri Institute of Medical Sciences and Research Center Institutional Ethics Committee |
Approved |
| Surakshaka Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HIV-I Infected patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nevirapine Tab. |
Nevirapine Prolonged-Release 400 mg tablets, orally, 400mg per day upto 18 Days |
| Comparator Agent |
VIRAMUNE |
Nevirapine Prolonged-Release Tablets 400 mg, orally, 400mg per day upto 18 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Signed and dated written informed consent prior to admission to the study in accordance with Good
Clinical Practice (GCP) and the local regulatory requirements.
2. Male and Non pregnant, non-lactating female subjects 18-65 years of age with documented HIV-I infection
3. BMI 18.5-30 mg/m2
4. Already receiving stable Nevirapine based regimen either immediate release or prolonged release
(for at least 14 days) in combination with:
a. Zidovudine and Lamivudine or
b. Tenofovir and Lamivudine as separately prescribed components and to be kept constant
throughout the study
5. An HIV viral load < 50 copies/mL at screening
6. A CD4+ T cell count > 50 cell/mm3
|
|
| ExclusionCriteria |
| Details |
1. History of allergy or hypersensitivity reactions to Nevirapine or the ingredients of the formulation
2. Current treatment with an HIV protease inhibitor
3. Clinically significant cardiac, liver or kidney disease
4. Having moderate to severe renal dysfunction or serum creatinine > 3 X ULN
5. Females who have a positive pregnancy test during screening or breast feeding or subjects not willing to take appropriate contraceptive measures to prevent pregnancy during the study
6. Patients with severe hepatic impairment (Child-Pugh C)
7. ALT or AST > 3 X ULN, Bilirubin > 2 X ULN
8. Any contraindication to use of Nevirapine
9. Past history or currently suffering from tuberculosis
10. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion
11. 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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cmaxss, AUCtau, Tmaxss, Cminss, Ctauss, Cavss and % Fluctuation for Nevirapine |
2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 15.00, 16.00, 17.00, 18.00, 19.00, 20.00, 21.00, 22.00, 23.00 and 24.00 hours after post dose |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
16/02/2015 |
| 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="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The sponsor has developed the
test formulation. This study is being conducted to compare the bioavailability
and characterize the Pharmacokinetic profile of the sponsor’s formulatons (Nevirapine Prolonged Release 400 mg tablets) with
reference formulation (VIRAMUNE Prolonged Release 400 mg tablets) in HIV-I Infected patients
under fasting conditions, stabilized on Nevirapine
based regimen either immediate release or prolonged release to assess the
bioequivalence. The most serious adverse reactions associated with
nevirapine are hepatitis, hepatic failure, Stevens- Johnson syndrome, toxic
epidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failure
may be isolated or associated with signs of hypersensitivity which may include
severe rash or rash accompanied by fever, general malaise, fatigue, muscle or
joint aches, blisters, oral lesions, conjunctivitis, facial edema,
eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunction
etc., regulatory authorities are
recommending that studies should be conducted on HIV-I infected patients. Since the formaulation being studied is a modified
release formaulation, a multiple dose, stady state study is being conducted as
per applicable regulatory guidance. The study is being conducted on
schizophrenic patients who are on a stable dose of Nevirapine based regimen,
and the patient cannot be deprived of the Nevirapine treatment during the
washout period of the study. Hence, the study has been planned to be a
continuous administration of the test and reference formulation without any
intervening washout period. Objective: To evaluate the pharmacokinetic
bioequivalence of the test and reference products and to monitor safety of the
patients. The total number of patients to enroll is around 36 from India. |