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To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets

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.
 
ClinicalTrials.gov Identifier: NCT00913419
Recruitment Status : Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Study Description
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Brief Summary:
To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.

Condition or disease Intervention/treatment Phase
Depression Drug: Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories Drug: Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bioavailability of Cyclobenzaprine HCl Tablets
Study Start Date : November 1988
Actual Primary Completion Date : December 1988
Actual Study Completion Date : December 1988

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 33 days ]

Eligibility Criteria
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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
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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
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Principal Investigator: A. Orson Brod, M.D. PharmaKineticsLaboratories, Inc
More Information
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Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00913419    
Other Study ID Numbers: 9038A
First Posted: June 4, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: June 2009
Keywords provided by Sandoz:
Antidepressant
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Amitriptyline
Cyclobenzaprine
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