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

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ClinicalTrials.gov Identifier: NCT00913549
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets
Study Start Date : December 1989
Primary Completion Date : January 1990
Study Completion Date : January 1990

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 19 days ]


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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913549


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

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
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: June 2009

Keywords provided by Sandoz:
Antihistamine

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