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

NCT00865943 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-08-17

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • James D. Carlson,, Pharm.D, · PRACS Institute, Ltd.

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2003-08-31
Completion
2003-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00865943 on ClinicalTrials.gov