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

Inclusion Criteria: * Were in the age range of 18-45 years. * Were neither overweight nor underweight for the corresponding 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. * Were non-vegetarian. There was no deviation in this regard. Exclusion Criteria: * Had a history of hypersensitivity to acetaminophen or to any of the components of the formulation. * Had a history of skin rashes, thrombocytopenia, urticaria or angioedema. * Had a history of peptic ulcer. * Had recent history of nausea and vomiting * Showed any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. * Showed presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection. * Showed presence of values which were significantly different from normal reference ranges defined 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) * Showed 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. * Showed 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). * Showed clinically abnormal ECG or Chest X-ray. * Had a history of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma. * Had a history of any psychiatric illness, which might 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. * 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, had donated and/or lost more than 350 mL of blood in the past 3 months. There was no deviation in this regard.