We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00913419
First Posted: June 4, 2009
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
June 2, 2009
June 4, 2009
March 28, 2017
November 1988
December 1988   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 33 days ]
Same as current
Complete list of historical versions of study NCT00913419 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets
Bioavailability of Cyclobenzaprine HCl Tablets
To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Depression
  • Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories
  • Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 1988
December 1988   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
19 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00913419
9038A
Not Provided
Not Provided
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: A. Orson Brod, M.D. PharmaKineticsLaboratories, Inc
Sandoz
June 2009

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