NCT00650325

Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Sertraline Hydrochloride Tablets (100 mg; Mylan) and Zoloft® Tablets (100 mg; Pfizer) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (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 sertraline hydrochloride 100 mg tablets to Pfizer's Zoloft® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sertraline Hydrochloride Tablets 100 mg	100mg, single dose fasting
DRUG	Zoloft® Tablets 100 mg	100mg, single dose fasting

Timeline

• Start date: 2002-11-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States