NCT00864019

A Relative Bioavailability Study of Sertraline HCl 100 mg Tablets Under Non-fasting Conditions

A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Sertraline 100 mg Tablets Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To compare the rate of absorption and oral bioavailability of a test formulation of Sertraline 100 mg tablets manufactured by Purepac Pharmaceutical Company to an equivalent oral dose of the commercially available reference product, Zoloft® manufactured by Pfizer Inc. Following an overnight fast of at least 10 hours, subjects will consume a standard high-calorie, high-fat breakfast meal. This standard breakfast will begin 30 minutes prior to each dose.

Detailed description

Study Type: Interventional Study Design: A single-dose, open-label, randomized, two-period crossover study Official Title: A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalence Study of Sertraline 100 mg Tablets Under Fed Conditions Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Sertraline HCl 100 mg tablets, single dose	A: Experimental SSubjects received Purepac formulated products under non-fasting conditions
DRUG	Zoloft® 100 mg tablets, single dose	B: Active comparator Subjects received Pfizer formulated products under non-fasting conditions

Timeline

• Start date: 2004-08-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2009-03-18
• Last updated: 2010-08-16

Locations

1 site across 1 country: United States