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

Inclusion Criteria: Aged 18-45 years. * Had a non-vegetarian diet. * Were neither overweight nor underweight for their 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: * Had history of hypersensitivity to acetaminophen or to any of the components of the formulation. * Had any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. * Had presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection. * Had 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. * Were positive for urinary screen testing of drugs of abuse (opiates or cannabinoids). * Had 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. * Had clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive). * Had clinically abnormal ECG or Chest X-ray. * Had history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma (rise of pressure inside the eye leading to blurring or loss of vision). * Had history of any psychiatric illness, which may impair the ability to provide written informed consent. * Were regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period. * Had 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. * Had used any enzyme modifying drugs within 30 days prior to Day 1 of this study. * Had participated in any clinical trial within 12 weeks preceding Day 1 of this study. * Subjects who, through completion of this study, had donated and/or lost more than 350 mL of blood in the past 3 months.