To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets

This study has been completed.

Sponsor:

Information provided by:

Sandoz

ClinicalTrials.gov Identifier:

NCT00913419

First received: June 2, 2009

Last updated: June 3, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 2, 2009

Last Updated Date

June 3, 2009

Start Date ^ICMJE

November 1988

Primary Completion Date

December 1988 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bioequivalence based on AUC and Cmax [ Time Frame: 33 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00913419 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets

Official Title ^ICMJE

Bioavailability of Cyclobenzaprine HCl Tablets

Brief Summary

To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories
Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme

Study Arm (s)

Experimental: 1
Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories

Intervention: Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories
Active Comparator: 2
Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme

Intervention: Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 1988

Primary Completion Date

December 1988 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

19 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00913419

Other Study ID Numbers ^ICMJE

9038A

Has Data Monitoring Committee

Not Provided

Responsible Party

Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.

Study Sponsor ^ICMJE

Sandoz Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

A. Orson Brod, M.D.

PharmaKineticsLaboratories, Inc

Information Provided By

Sandoz

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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