Trials / Completed
CompletedNCT00840398
Buspirone Hydrochloride 30mg Tablets, Non-Fasting
A Relative Bioavailability Study of 30 mg Buspirone Hydrochloride Tablets Under Non-Fasting Conditions
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Teva Pharmaceuticals USA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg tablet) in healthy adult volunteers under non-fasting conditions.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BUSPAR® 30 mg Tablet | 1 x 30 mg, single-dose fed |
| DRUG | Buspirone Hydrochloride 30 mg Tablet | 1 x 30 mg, single-dose fed |
Timeline
- Start date
- 2001-12-01
- Primary completion
- 2001-12-01
- Completion
- 2001-12-01
- First posted
- 2009-02-10
- Last updated
- 2024-08-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00840398. Inclusion in this directory is not an endorsement.