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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/02/005493
Enrollment
36
Registered
2015-02-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- HIV-I Infected patients

Interventions

Intervention1: Nevirapine Tab.: Nevirapine Prolonged-Release 400 mg tablets, orally, 400mg per day upto 18 Days Control Intervention1: VIRAMUNE: Nevirapine Prolonged-Release Tablets 400 mg, orally, 40

Sponsors

MYLAN LABORATORIES LIMITED
Lead Sponsor
Cliantha Research India Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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 6. A CD4+ T cell count > 50 cell/mm3

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactMr Kunal Sehra

Cliantha Research Limited

cshah@clianthatrials.com07966135631

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026