NCT00648193

Fasting Study of Paroxetine Hydrochloride Tablets 40 mg and Paxil® Tablets 40 mg

Single-Dose Fasting Bioequivalence Study of Paroxetine Hydrochloride Tablets (40 mg; Mylan) and Paxil® Tablets (40 mg; GSK) in Healthy Adult Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to investigate the bioequivalence of Mylan's paroxetine hydrochloride 40 mg tablets to GSK's Paxil® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions to healthy adult volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Paroxetine hydrochloride 40 mg tablet	40mg, single dose fasting
DRUG	Paxil® 40 mg Table	40mg, single dose fasting

Timeline

• Start date: 2006-12-01
• Primary completion: 2006-12-01
• Completion: 2007-01-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States