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NCT00913549 Clinical Trial

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

Allergy Clinical Trial

Official title:
Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00913549
Other study ID # 239-04
Secondary ID
Status Completed
Phase Phase 1
First received June 2, 2009
Last updated March 27, 2017
Start date December 1989
Est. completion date January 1990

Study information
Verified date June 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date January 1990
Est. primary completion date January 1990
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Clemastine Fumarate Tablets, 2.68 mg (Cord Laboratories)

• Tavist Tablets, 2.68 mg (Sandoz Pharmaceutical Corp.)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 19 days
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