Trials / Completed
CompletedNCT00647881
Food Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg
Single-Dose Food In Vivo Bioequivalence Study of Paroxetine Hydrochloride Controlled-Release Tablets (25 mg; Mylan) to Paxil CR™ Tablets (25 mg; GlaxoSmithKline) in Healthy Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Mylan Pharmaceuticals Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to investigate the bioequivalence of Mylan's paroxetine hydrochloride controlled-release 25 mg tablets to GSK's Paxil CR™ 25 mg tablets following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Paroxetine Hydrochloride Controlled-Release Tablets 25 mg | 25mg, single dose fed |
| DRUG | Paxil CR™ Tablets 25 mg | 25mg, single dose fed |
Timeline
- Start date
- 2005-04-01
- Primary completion
- 2005-05-01
- Completion
- 2005-05-01
- First posted
- 2008-04-01
- Last updated
- 2024-04-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00647881. Inclusion in this directory is not an endorsement.