NCT00650065

Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mg

Single-Dose Fasting In Vivo Bioequivalence Study of Cetirizine HCl Tablets (10 mg; Mylan) and Zyrtec® Tablets (10 mg; Pfizer) in Healthy Volunteers

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

Summary

"The objective of this study was to investigate the bioequivalence of Mylan cetirizine HCl 10 mg tablets to Pfizer's Zyrtec® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cetirizine HCl Tablets 10 mg	10mg, single dose fasting
DRUG	Zyrtec® Tablets 10 mg	10mg, single dose fasting

Timeline

• Start date: 2002-11-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States