NCT00778037

Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Cyclobenzaprine hydrochloride 10 mg tablet

Timeline

• Start date: 2006-09-01
• Primary completion: 2006-09-01
• Completion: 2006-11-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: India