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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: June 3, 2009
Last verified: June 2009
History of Changes
  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
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:

MedlinePlus related topics: Depression
U.S. FDA Resources

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

  Eligibility

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

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

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov 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:
Antidepressant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Cyclobenzaprine
Amitriptyline
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013