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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: March 27, 2017
Last verified: June 2009
June 2, 2009
March 27, 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
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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: No masking
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
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*   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
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NCT00913419
9038A
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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