To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets

This study has been completed.
Information provided by:
Sandoz Identifier:
First received: June 2, 2009
Last updated: June 3, 2009
Last verified: June 2009
To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.

Condition Intervention Phase
Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories
Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioavailability of Cyclobenzaprine HCl Tablets

Resource links provided by NLM:

Further study details as provided by Sandoz:

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

Enrollment: 30
Study Start Date: November 1988
Study Completion Date: December 1988
Primary Completion Date: December 1988 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories
Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories
Active Comparator: 2
Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme
Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme


Ages Eligible for Study:   19 Years to 50 Years
Genders 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
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Please refer to this study by its identifier: NCT00913419

Sponsors and Collaborators
Sandoz Inc.
Principal Investigator: A. Orson Brod, M.D. PharmaKineticsLaboratories, Inc
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc. Identifier: NCT00913419     History of Changes
Other Study ID Numbers: 9038A 
Study First Received: June 2, 2009
Last Updated: June 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics, Non-Narcotic
Antidepressive Agents
Antidepressive Agents, Tricyclic
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Tranquilizing Agents processed this record on May 26, 2016