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

Overview

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

Full Title of Study: “Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: January 1990

Interventions

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

Arms, Groups and Cohorts

• Experimental: 1
  • Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
• Experimental: 2
  • Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)

Clinical Trial Outcome Measures

Primary Measures

• Bioequivalence based on AUC and Cmax
  • Time Frame: 19 days

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 19 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Sandoz
• Provider of Information About this Clinical Study
  • Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
• Overall Official(s)
  • James C. Kisicki, M.D., Principal Investigator, Harris Laboratories, Incorporated