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

The sponsor has developed thetest formulation. This study is being conducted to compare the bioavailabilityand characterize the Pharmacokinetic profile of the  sponsor’s formulatons (Nevirapine Prolonged Release 400 mg tablets) withreference formulation (VIRAMUNE Prolonged Release 400 mg tablets) in HIV-I Infected patientsunder fasting conditions, stabilized on Nevirapinebased regimen either immediate release or prolonged release to assess thebioequivalence. The most serious adverse reactions associated withnevirapine are hepatitis, hepatic failure, Stevens- Johnson syndrome, toxicepidermal necrolysis, and hypersensitivity reactions. Hepatitis/hepatic failuremay be isolated or associated with signs of hypersensitivity which may includesevere rash or rash accompanied by fever, general malaise, fatigue, muscle orjoint aches, blisters, oral lesions, conjunctivitis, facial edema,eosinophilia, granulocytopenia, lymphadenopathy, or renal dysfunctionetc.,   regulatory authorities arerecommending that studies should be conducted on  HIV-I infected patients.    Since the formaulation being studied is a modifiedrelease formaulation, a multiple dose, stady state study is being conducted asper applicable regulatory guidance. The study is being conducted onschizophrenic patients who are on a stable dose of Nevirapine based regimen,and the patient cannot be deprived of the Nevirapine treatment during thewashout period of the study. Hence, the study has been planned to be acontinuous administration of the test and reference formulation without anyintervening washout period. Objective: To evaluate the pharmacokineticbioequivalence of the test and reference products and to monitor safety of thepatients. The total number of patients to enroll is around 36 from India.