NCT00865085

A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions

Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate and compare the relative bioavailability, and therefore the bioequivalence of two formulations of Citalopram after a single dose administration under fasting conditions.

Detailed description

Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design. Official Title: Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State 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 40 mg tablets, single dose	A: Experimental Subjects received Purepac formulated products under fasting conditions
DRUG	CelexaTM 40 mg tablets, single dose	B: Active comparator Subjects received Forest Labs formulated products under fasting conditions

Timeline

• Start date: 2003-06-01
• Primary completion: 2003-07-01
• Completion: 2003-07-01
• First posted: 2009-03-19
• Last updated: 2010-08-17

Locations

1 site across 1 country: Canada