To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets

Phase 1

Completed

• Conditions: Allergy
• Interventions: Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.); Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)

• Registration Number: NCT00913549
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 1989-12
• Primary Completion: 1990-01
• Study Completion: 1990-01
• Status Verified: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-03
• Study First Posted: 2009-06-04
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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	Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)	Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)
1	Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)	Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	19 days