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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00913549
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Allergy
 Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 19 days ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: December 1989
Study Completion Date: January 1990
Primary Completion Date: January 1990 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
 Drug: Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)
Experimental: 2
Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)
 Drug: Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00913549

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: James C. Kisicki, M.D. Harris Laboratories, Incorporated
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913549     History of Changes
Other Study ID Numbers: 239-04
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antihistamine

Additional relevant MeSH terms:
Clemastine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
 Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 21, 2013