Trials / Completed
CompletedNCT00477126
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir® in Thai Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration · Academic / Other
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
Detailed description
This study will be performed to evaluate if the new generic GPO ritonavir product is bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GPO ritonavir versus Norvir | RTV generic compared to reference drugs (Norvir, Abbott) |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2007-02-01
- Completion
- 2007-02-01
- First posted
- 2007-05-22
- Last updated
- 2012-04-05
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT00477126. Inclusion in this directory is not an endorsement.