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A Relative Bioavailability Study of Cetirizine HCl 10 mg Tablets Under Fasting Conditions

NCT00864279 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2010-08-16

No results posted yet for this study

Summary

To determine the pharmacokinetics and bioequivalence of cetirizine hydrochloride formulations after administration of single doses to normal healthy subjects under fasted conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Conditions

  • Healthy

Interventions

DRUG

Cetirizine Hydrochloride 10 mg tablets, single dose

A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fast conditions

DRUG

Zyrtec® 10 mg tablets, single dose

B: Active comparator Subjects received Pfizer Inc. formulated products under fast conditions

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Evin H. Sides III,, MD · AAI Clinic (AAIPharma Inc.)

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2006-09-30
Completion
2006-09-30

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 NCT00864279 on ClinicalTrials.gov