NCT00648427

Fasting Study of Paroxetine Hydrochloride Controlled-Release Tablets 25 mg to Paxil CR™ Tablets 25 mg

Single-Dose Fasting 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 fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Paroxetine Hydrochloride Controlled-Release Tablets 25 mg	25mg, single dose fasting
DRUG	Paxil CR™ Tablets 25 mg	25mg, single dose fasting

Timeline

• Start date: 2005-04-01
• Primary completion: 2005-04-01
• Completion: 2005-05-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States