NCT00776139

Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions

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 Fasting Condition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: —
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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 fasting condition

Detailed description

The study was conducted as an open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability of the test formulation of cetirizine hydrochloride tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) containing containing 10 mg cetirizine hydrochloride study comparing to the marketed product, Zyrtec®, containing 10 mg of cetirizine hydrochloride of Pfizer Labs (Division of Pfizer Inc.), in healthy, adult, human, subjects under fasting condition. Safety measures were performed throughout the study and included a physical examination, laboratory evaluation, and measurement of vital signs. A total of 32 subjects were randomized to receive single oral dose of cetirizine hydrochloride 10 mg tablet and 31 subjects completed both the periods of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cetirizine Hydrochloride 10 mg tablet	Bioequivalence Cetirizine Hydrochloride 10 mg tablet

Timeline

• Start date: 2004-10-01
• Primary completion: 2004-10-01
• Completion: 2004-12-01
• First posted: 2008-10-20
• Last updated: 2008-10-20

Locations

1 site across 1 country: United States