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
- Conditions
- Health Condition 1: null- HIV Patients
- Registration Number
- CTRI/2016/10/007330
- Lead Sponsor
- Hetero Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 38
•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
•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.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC(0-Ï?), Cmax,ss, CÏ?,ss, tmax,ss, Cmin, ss and fluctuation for NevirapineTimepoint: 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 Measures
Name Time Method To monitor the adverse events and to ensure the safety & tolerability of the patientsTimepoint: NI