NCT03772158

Cetirizine Chewable Bioequivalence and Food Effect Study

A Randomized, Single-Dose, Four-Treatment Crossover Bioequivalence and Food Effect Study of Test Formulation of Cetirizine 10mg Chewable Tablets Versus Two Marketed Cetirizine 10mg Immediate Release Tablets.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine and compare the amount of study drug that gets into your blood after the administration of each of the three formulations of cetirizine under different conditions. Another objective of this study is to evaluate the effect of food on the amount of study drug that gets into your blood after the administration of the investigational formulation. Other objectives of this study are to determine the sensory experience and ease of swallowing the investigational formulation, as well as to determine the safety of test and reference formulations of cetirizine.

Detailed description

The purpose of this study is to establish bioequivalence of a cetirizine 10 mg chewable tablet manufactured at Johnson \& Johnson Consumer Inc. (McNeil LLC) with two commercially marketed cetirizine 10 mg immediate release (IR) tablets (ZYRTEC®, US reference) and (Australian/EU reference), establish bioequivalence between the two commercial products (ZYRTEC®, US reference and REACTINE®, Australian/EU reference), and to evaluate the effect of food on bioavailability of the cetirizine 10 mg chewable tablet compared to the bioavailability of cetirizine 10 mg chewable tablet administrated with water only. In addition, subject's sensory experience and ease of swallowing of the test product will be assessed.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	Cetirizine 10mg	Chewable tablet
DRUG	Cetirizine 10 mg	Immediate Release Tablet
DRUG	Cetirizine 10 mg	Immediate Release Tablet

Timeline

• Start date: 2018-12-11
• Primary completion: 2019-02-03
• Completion: 2019-02-03
• First posted: 2018-12-11
• Last updated: 2021-12-01

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study