A Relative Bioavailability Study of Acetaminophen Extended Release Gel Tabs 650 mg Under Fasting Condition

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study was to compare single-dose oral bioavailability of acetaminophen 650 mg extended release geltabs (containing acetaminophen 650 mg) of OHM Laboratories Inc. (subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with Tylenol 8 hour extended release gel tabs (containing acetaminophen 650 mg) of McNeil Consumer & Speciality Pharmaceuticals, U.S.A 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: Acetaminophen

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:

• History of hypersensitivity to Acetaminophen or to any of the components of the formulation.

• History of skin rashes, thrombocytopenia, urticaria or angioedema

• 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 that 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 haematological disease, diabetes or glaucoma (rise of pressure inside the eye leading to blurring or loss of vision)

• 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.

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

• Participation 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.