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Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fed Conditions

NCT00776022 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2010-03-02

No results posted yet for this study

Summary

An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fed condition

Conditions

  • Healthy

Interventions

DRUG

Cetirizine Hydrochloride 10 mg tablet

Bioequivalence Cetirizine Hydrochloride 10 mg tablet fed conditions

Sponsors & Collaborators

  • Ohm Laboratories, Inc.

    collaborator INDUSTRY

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2005-04-30
Completion
2005-06-30

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 NCT00776022 on ClinicalTrials.gov