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 â??VIRAMUNEâ?? (Nevirapine) Prolonged-Release Tablets 400 mg of Boehringer Ingelheim International GmbH in HIV-I Infected Patients Under Fasting Conditions - NA

MYLAN LABORATORIES LIMITED0 个研究点目标入组 36 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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•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

•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

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