NCT01322282

To Test Bioequivalence Between Two Tablet Formulations in the Treatment of Allergy

A Randomized, Open-Label, Single-Dose, Three-Period Crossover Bioequivalence Study to Compare an Orodispersible Tablet (ODT) Formulation of Cetirizine HCl 10 mg Taken With and Without Water Compared With a Standard Marketed 10 mg Tablet Taken With Water

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: McNeil AB · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess bioequivalence between two products used for treatment of allergy.

Detailed description

This study is designed to evaluate if a test formulation of cetirizine 10 mg orodispersible tablet (ODT) taken with and without water is bioequivalent to a marketed reference formulation of cetirizine 10 mg tablet (Benadryl One A Day, McNeil Products Ltd, UK) taken with water. This study will also evaluate the tolerability of test and reference formulations.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	Cetirizine	A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
DRUG	Cetirizine	A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-03-24
• Last updated: 2012-07-10

Locations

1 site across 1 country: Canada