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

  1. 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
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2017