To Demonstrate the Relative Bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg Extended Release (ER) Tablets Under Fed Conditions

Phase 1

Completed

• Conditions: Allergies
• Interventions: Drug: Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA); Drug: Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)

• Registration Number: NCT00881634
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioavailability of Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride 5 mg/120 mg ER tablets under fed conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Status Verified: 2009-04
• Study First Submitted: 2009-04-13
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)	Zyrtec-D 12 Hour 5 mg/120 mg Extended Release Tablets (Pfizer, USA)
1	Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)	Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	10 days