Trials / Completed
CompletedNCT00834431
Famciclovir 500 mg Tablets Under Fasting Conditions
A Single Dose, Comparative Bioavailability Study of Two Formulations of Famciclovir 500 mg Tablets Under Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Famciclovir 500 mg Tablets | 1 x 500 mg, single-dose fasting |
| DRUG | Famvir® 500 mg Tablets | 1 x 500 mg, single-dose fasting |
Timeline
- Start date
- 2004-08-01
- Primary completion
- 2004-09-01
- Completion
- 2004-09-01
- First posted
- 2009-02-03
- Last updated
- 2024-08-20
- Results posted
- 2009-08-04
Locations
2 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00834431. Inclusion in this directory is not an endorsement.