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

Hetero Labs Limited0 个研究点目标入组 38 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

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