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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Amitriptyline; Cyclobenzaprine

Criteria

Inclusion Criteria:

• Were in the age range of 18-45 years.

• Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.

• Had voluntarily given written informed consent to participate in this study

• Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.

Exclusion Criteria:

• - Hypersensitivity or allergy to Cyclobenzaprine hydrochloride or related group of drugs.

• Use of MAO Inhibitors in the past 2 weeks / history of Hyperthyroidism.

• History of hypotension, dizziness, syncope or those who had previously experienced a hypotensive response to other medications.

• History of arrhythmia, heart block or congestive heart failure.

• History of urinary disorders especially urinary retention.

• History of seizures, tinnitus, tremors, visual disorders, psychosomatic illness, recurrent palpitations, Jaundice.

• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.

• Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.

• Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.

• Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)

• Presence of values which were significantly different from normal reference ranges and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.

• Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive).

• Clinically abnormal ECG or Chest X-ray.

• History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes, glaucoma or increased intra ocular pressure.

• History of any psychiatric illness which might impair the ability to provide written informed consent.

• Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.

• History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.

• Used any enzyme modifying drugs within 30 days prior to Day 1 of this study.

• Participated in any clinical trial within 12 weeks preceding Day 1 of this study.

• Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.