FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/10/007330 [Registered on: 04/10/2016] Trial Registered Retrospectively
Last Modified On: 19/07/2017
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 (Hetero Labs 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   A randomized, open-label, balanced, two-treatment, two-period, two-sequence, single/multicentre, multiple dose (steady state), two-way crossover, oral bioequivalence study of Nevirapine 400 mg Prolonged-Release Tablets manufactured by Hetero Labs Limited, India and Viramune 400 mg prolonged-release tablets of Boehringer Ingelheim International GmbH, Germany in 38 adult HIV1 infected patients under fasting conditions 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
127-15-EM 00 27 Oct 2015  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr A Kiran Kumar 
Designation  Head - Operations 
Affiliation  CRBio ( A Division of RA CHEM PHARMA) 
Address  RA CHEM PHARMA LTD CLINICAL RESEARCH AND BIOSCIENCES DIVISION Plot no 26 and 27, Technocrat Industrial Estate Balanagar

Hyderabad
ANDHRA PRADESH
500037
India 
Phone  040-44758595  
Fax  040-44758596  
Email  kirankumar@crbio.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr LKrishna Murthy 
Designation  Head Clinical Operations  
Affiliation  CRBio ( A Division of RA CHEM PHARMA) 
Address  RA CHEM PHARMA LTD CLINICAL RESEARCH AND BIOSCIENCES DIVISION Plot no 26 and 27, Technocrat Industrial Estate Balanagar

Hyderabad
ANDHRA PRADESH
500037
India 
Phone  040-44758595  
Fax  040-44758596  
Email  drmurthy@crbio.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sagar Bhosale 
Designation  Manager - Clinical 
Affiliation  CRBio ( A Division of RA CHEM PHARMA) 
Address  RA CHEM PHARMA LTD CLINICAL RESEARCH AND BIOSCIENCES DIVISION Plot no 26 and 27, Technocrat Industrial Estate Balanagar

Hyderabad
ANDHRA PRADESH
500037
India 
Phone  040-44758595  
Fax  040-44758596  
Email  drsagar@crbio.co.in  
 
Source of Monetary or Material Support  
Sponsor  
 
Primary Sponsor  
Name  Hetero Labs Limited 
Address  7-2-A2, Hetero Corporate, Industrial Estates, Sanathnagar, Hyderabad – 500 018. Telangana India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Phatak  Dr Hedgewar Hospital  Garkheda, Aurangabad, Maharashtra- 431005, INDIA.
Aurangabad
MAHARASHTRA 		 9822435505

dranandphatak@yahoo.co.in 
Dr Swati C Aundhkar  Krishna Institiue of Medical Science  KIMS ,Karad, Maharashtra – 415110, INDIA.
Satara
MAHARASHTRA 		 9552653351

drsaundhakar@gmail.com 
Dr Keyur Shah  Medilink Hospital Research Centre  Department of Medicine, 1st Floor, Nr.Shyamal Cross Road, 132.ft ring Road,Satellite, Ahmedabad Ahmadabad GUJARAT
Ahmadabad
GUJARAT 		 07926743051

drkeyurshah@yahoo.com 
Dr Prakash H Kurmi  Ratandeep Multi Speciality Hospital  Nakshatra complex, Above HDFC Bank, Maninagar Cross road, Maninagar Ahemedbad-380008, INDIA
Ahmadabad
GUJARAT 		 9825047692

dr_prakashkurmi@yahoo.co.in 
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
Bangalore
KARNATAKA 		 9448696741

urvashibhatara@gmail.com 
Dr Dileep Kadam  Sasson Government Hospital.   B.J Government Medical college and Sasson Government hospital. Sasson Road, Pune, Maharashtra -411001, INDIA
Pune
MAHARASHTRA 		 9890716263

dr.dumbreumesh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Hegdewar Ethics Committee  Approved 
KIMS  Approved 
Medilink Ethics Committee   Approved 
Ratandeep Instutional Ethics committe  Approved 
Sapthagiri   Approved 
Sasson Hospital  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  HIV Patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nevirapine Tab.  Nevirapine Extended Release Tablet 400 mg of Hetero lab. Oral, Once daily for 08 Days  
Comparator Agent  Viramune® XR   Viramune 400 mg prolonged-release tablets of Boehringer Ingelheim International GmbH, Germany  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  •HIV-I infected adult male or non-pregnant, non-lactating female patients, 18-45 years of age (both inclusive).
•Subjects willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent.
•BMI 18.5-30 kg/m2, diagnosed with documented HIV-I infection.
•Patient who is already receiving Nevirapine 400 mg per day in combination with at least two antiretroviral drugs for at least 14 days prior to first IMP administration.
•An HIV viral load < 50 copies/mL at screening.
•CD4 counts >50/mm3 at screening
•History of adequate renal, hepatic and cardiac function

 
 
ExclusionCriteria 
Details  •A history of allergic or adverse reactions to Nevirapine or any comparable or similar product.
•Current treatment with an HIV protease inhibitor.
•Patients with moderate or severe hepatic impairment Child Pugh B or C.
•Screening AST or ALT > 2.5 ULN.
•History of liver function abnormalities upon re-administration of Nevirapine.
•History or presence of cancer.
•Use of concomitant medication (other than the stable background antiretroviral HIV therapy) that may interfere with the pharmacokinetics of Nevirapine within 14 days prior to first dosing.
•Difficulty in swallowing solids like tablets or capsules.
•Patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery.
•Patients with known positivity for HbsAg and HCV.
•An unusual or abnormal diet, for whatever reason e.g. religious fasting.
•Subject participating in any other clinical study or has received treatment with any investigational drug or device within 90 days prior to first dose of investigational medicinal product for the current study.
•Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
•History of difficulty with donating blood or difficulty in accessibility of veins.
 
 
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 
AUC(0-Ï„), Cmax,ss, CÏ„,ss, tmax,ss, Cmin, ss and fluctuation for Nevirapine   predose 0.00, 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 post dose 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety & tolerability of the patients  NIL 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
Final Enrollment numbers achieved (Total)= "38"
Final Enrollment numbers achieved (India)="38" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/03/2016 
Date of Study Completion (India) 26/07/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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,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, steady state study is being conducted as per applicable regulatory guidance. The study is being conducted on HIV infected 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 38 from India.
 
Close