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.