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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
  Purpose
To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.

Condition Intervention Phase
Depression 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
Intervention Model: Crossover Assignment
Masking: None (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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913419


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913419     History of Changes
Other Study ID Numbers: 9038A
First Submitted: June 2, 2009
First Posted: June 4, 2009
Last Update Posted: March 28, 2017
Last Verified: June 2009

Keywords provided by Sandoz:
Antidepressant

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