NCT00836849

Sertraline Hydrochloride 100 mg Tablets, Fasting

Randomized, 2-Way Crossover, Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets and Zoloft® 100 mg Tablets Administered as 1 x 100 mg Tablet in Healthy Subjects Under 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: Not accepted

Summary

The objective of this study is to compare the rate and extent of absorption of sertraline hydrochloride 100 mg tablets (test) versus Zoloft® (reference) administered as 1 x 100 mg tablet under fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Zoloft® 100 mg Tablets	1 x 100 mg, single-dose fed
DRUG	Sertraline hydrochloride 100 mg Tablets	1 x 100 mg, single-dose fed

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-04-01
• Completion: 2002-04-01
• First posted: 2009-02-04
• Last updated: 2024-08-19

Locations

1 site across 1 country: Canada