To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets
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ClinicalTrials.gov Identifier: NCT00913419 |
Recruitment Status :
Completed
First Posted : June 4, 2009
Last Update Posted : March 28, 2017
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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 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 |

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 |
- Bioequivalence based on AUC and Cmax [ Time Frame: 33 days ]

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Ages Eligible for Study: | 19 Years to 50 Years (Adult) |
Sexes 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.

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
Principal Investigator: | A. Orson Brod, M.D. | PharmaKineticsLaboratories, Inc |
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 |
Antidepressant |
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 |