Bioequivalence study comparing Nevirapine Prolonged Release 400 mg tablets (Mylan Laboratories 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-I Infected patients
- Registration Number
- CTRI/2015/02/005493
- Lead Sponsor
- MYLAN LABORATORIES LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 36
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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmaxss, AUCtau, Tmaxss, Cminss, Ctauss, Cavss and % Fluctuation for NevirapineTimepoint: 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 after post dose
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI