To Demonstrate the Relative Bioequivalency Study of Dosage Forms of Clemastine 2.68 mg Tablets
Sponsor
Sandoz (Industry)
Overall Status
Completed
CT.gov ID
NCT00913549
Collaborator
(none)
36
2
1
Study Details
Study Description
Brief Summary
To demonstrate the relative bioequivalency study of dosage forms of Clemastine 2.68 mg tablets.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
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
:
Dec 1, 1989
Actual Primary Completion Date
:
Jan 1, 1990
Actual Study Completion Date
:
Jan 1, 1990
Arms and Interventions
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.)
|
Outcome Measures
Primary Outcome Measures
- Bioequivalence based on AUC and Cmax [19 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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
Locations
No locations specified.Sponsors and Collaborators
- Sandoz
Investigators
- Principal Investigator: James C. Kisicki, M.D., Harris Laboratories, Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00913549
Other Study ID Numbers:
- 239-04
First Posted:
Jun 4, 2009
Last Update Posted:
Mar 28, 2017
Last Verified:
Jun 1, 2009