NCT00865943

A Relative Bioavailability Study of Citalopram HBr 10 mg Tablets Under Fasting Conditions

A Relative Bioavailability of 10 mg Citalopram Hydrobromide Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is compare the relative bioavailability of 10 mg Citalopram Hydrobromide tablets by Purepac Pharmaceutical Co with that of 10 mg CELEXATM tablets distributed and marketed by Forest Pharmaceuticals, Inc. following a single oral dose (1 x 10 mg tablet) in healthy adult volunteers under fasting conditions

Detailed description

Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover study under fasting conditions Official Title: A Relative Bioavailability of 10 mg Citalopram Hydrobromide Tablets Under Fasting 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	Citalopram HBr eq. 10 mg tablets, single dose	A: Experimental Subjects received Purepac formulated products under fasting conditions
DRUG	CELEXATM 10 mg tablets, single dose	B: Active comparator Subjects received Forest Pharmaceuticals, Inc. marketed products under fasting conditions

Timeline

• Start date: 2003-07-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: United States