NCT00864279

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

Single Dose Two-Way Crossover Fasted Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers

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

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.

Detailed description

Study Type: Interventional Study Design: Single-dose two-way, crossover bioequivalence study with an adequate washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned to receive the study test (Treatment A) and study reference (Treatment B). Official Title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Cetirizine Hydrochloride 10 mg Tablets in Healthy Volunteers Further study details as provided by Actavis Elizabeth LLC: Primary Outcome Measures: Rate and Extend of Absorption

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-08-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2009-03-18
• Last updated: 2010-08-16

Locations

1 site across 1 country: United States