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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778037 |
To compare the single-dose oral bioavailability of Cyclobenzaprine hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg tablet (containing Cyclobenzaprine hydrochloride 10 mg) of McNeil Consumer & Specialty Pharmaceuticals, in healthy, adult, male, human subjects under fasting condition.
Condition | Intervention |
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Healthy |
Drug: Cyclobenzaprine hydrochloride 10 mg tablet |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open Label, Balanced, Randomized, Two-Treatment, Two-Sequence, Two-Period, Single-Dose, Crossover, Bioavailability Study Comparing Cyclobenzaprine Hydrochloride 10 mg Tablet of Ohm Labs Inc (A Subsidiary of Ranbaxy Pharmaceuticals Inc USA.) With Flexeril® 10 mg Tablet (Containing Cyclobenzaprine Hydrochloride 10 mg) Manufactured by Merck & Co Inc., USA and Distributed by McNeil Consumer & Speciality Pharmaceuticals, in Healthy, Adult, Male, Human Subjects Under Fasting Condition. |
Enrollment: | 40 |
Study Start Date: | September 2006 |
Study Completion Date: | November 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Cyclobenzaprine hydrochloride 10 mg tablet of ranbaxy
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Drug: Cyclobenzaprine hydrochloride 10 mg tablet |
2: Active Comparator
Flexeril® 10 mg tablets
|
Drug: Cyclobenzaprine hydrochloride 10 mg tablet |
The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover, bioavailability study comparing Cyclobenzaprine hydrochloride 10 mg tablet of Ohm Labs Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc USA.) with Flexeril® 10 mg tablet (containing Cyclobenzaprine hydrochloride 10 mg) manufactured by Merck & Co Inc., USA and distributed by McNeil Consumer & Speciality Pharmaceuticals, in healthy, adult, male, human subjects under fasting condition.
Following an overnight fast of at least 10 hours, A single oral dose of one Cyclobenzaprine hydrochloride 10 mg tablet was administered with 240 mL of drinking water at ambient temperature during each period of the study under supervision of a trained Study Personnel.
During the course of the study safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Laboratory parameters of hematology and biochemistry were repeated at the end of the study.
A total of forty (40) subjects were enrolled in the study. Out of which thirty-four (34) subjects completed both the periods of the study.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | 125_CYCLO_06 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778037 History of Changes |
Health Authority: | India: Drugs Controller General of India |
Bioequivalence Cyclobenzaprine hydrochloride 10 mg tablet fasting conditions |
Neurotransmitter Agents Tranquilizing Agents Adrenergic Agents Psychotropic Drugs Central Nervous System Depressants Healthy Cyclobenzaprine |
Antidepressive Agents, Tricyclic Analgesics, Non-Narcotic Muscle Relaxants, Central Amitriptyline Peripheral Nervous System Agents Analgesics Antidepressive Agents |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Neuromuscular Agents Pharmacologic Actions |
Cyclobenzaprine Antidepressive Agents, Tricyclic Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Muscle Relaxants, Central Amitriptyline Analgesics Peripheral Nervous System Agents Central Nervous System Agents Antidepressive Agents |