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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
  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:


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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
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:
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

ClinicalTrials.gov processed this record on September 30, 2016