Trials / Completed
CompletedNCT02202005
Multiple Dose BE Study With Nevirapine 400mg PR Tablets
A Multiple Dose, Open Label, Pivotal, 4 Period, 2 Treatment, Sequence Full Replicative Crossover Study to Assess the Bioequivalence (BE) of TEVA's Generic Once Daily Nevirapine 400 mg Prolonged Release (PR) Formulation Compared With the Approved Reference Product Viramune® 400 mg Prolonged Release Tablets Under Fasted Conditions in HIV1 Infected Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Ratiopharm GmbH · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this steady state pivotal study is to compare the rate and extent of absorption and to evaluate Bioequivalence of test drug compared to the approved reference product in HIV infected individuals
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nevirapine | Nevirapine 400mg PR tablet |
| DRUG | Viramune® | Viramune® 400 mg Retardtabletten |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2015-07-01
- Completion
- 2015-08-01
- First posted
- 2014-07-28
- Last updated
- 2015-08-25
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT02202005. Inclusion in this directory is not an endorsement.