FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Approved/Obtained 
 
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

 
Close