A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fed Condition

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP 20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical Co. Fort Washington, PA 19034 USA under fed conditions.

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

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Famotidine

Criteria

Inclusion Criteria:

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

• Were neither overweight nor underweight for their 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.

• Had a non-vegetarian diet habit.

There were no deviations in this regard.

Exclusion Criteria:

• History of hypersensitivity to famotidine and/or related group of drugs, including hypersensitivity to other H2 blockers.

• The subject had 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 range 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 range and/or judged clinically significant for serum creatinine, blood urea, 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.

• The subject had history of serious gastrointestinal, hepatic, renal, pulmonary, cardiovascular, neurological or haematological disease, diabetes or glaucoma.

• The subject had history of any psychiatric illness, which might impair the ability to provide written informed consent.

• The subject was a regular smoker who smoked more than 10 cigarettes daily or has difficulty abstaining from smoking for the duration of each study period.

• The subject 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.

• The subject 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.

There were no deviations in this regard.