An Open-Label, Randomized, Two-Treatment, Two Period, Two Sequence, Crossover, Multicentre, Multiple Dose, Steady State Bioequivalence study of Nevirapine Extended Release Tablet 400 mg of Apotex Inc. and ViramuneÂ® XR Extended-Release Tablet 400 mg of Boehringer Ingelheim Pty Limited., Australia in Patients Under Fasting Conditions.

Apotex Inc0 个研究点目标入组 30 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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•Subjects participating in the study must have:
•1.Able to understand and willing to sign the informed consent form
•2.Male and Non pregnant, non-lactating female subjects 18-65 years of age with documented HIV-I infection
•3.BMI 18-30 kg/m2
•4.Already receiving stable Nevirapine based regimen at least since 12 weeks either immediate release or extended release 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
•7.Willingness of study participants to comply with the all the study requirements
•8.Willingness of study participants to not plan a child during the study
•Clinically acceptable screening laboratory values that indicate adequate baseline organ function

•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 are pregnant or breast feeding or planning to become pregnant or subjects not willing to take appropriate measures to prevent pregnancy during the study
•6.ALT or AST >= 3 X ULN, Bilirubin > 2 X ULN
•7.Any contraindication to use of Nevirapine
•8.Past history or currently suffering from tuberculosis
•9.Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion
•10.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
•11.Consumption of grapefruit, grapefruit-like or grapefruit containing products within 7 days of drug administration.
•12.Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication (listed in Appendix-II). They can be allowed depending on Principal Investigatorâ??s discretion in consultation with Medical monitor, if they are kept constant in the last 30 days and are expected to remain constant during the study period.

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