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

NCT01079065 | Completed

• 1 other identifier: 261_FAMOT_07
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 fasting conditions.

Conditions

Healthy

Keywords

Famotidine tablets fasting study

Outcome Measures

Primary Outcomes (1)

• Bioequivalence evaluation of ranbaxy famotidine tablets 20mg with Pepcid® AC Acid reducer famotidine tablets 20 mg under fasting condition

Study Arms (2)

Test

EXPERIMENTAL

Famotidine Tablets, USP 20 mg of OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc., USA)

Drug: Famotidine

Reference

ACTIVE COMPARATOR

Pepcid® AC Acid reducer famotidine tablets 20 mg of Johnson \& Johnson. Merck Consumer Pharmaceutical Co. Fort Washington, PA 19034 USA

Drug: Famotidine

Interventions

Famotidine DRUG

Tablets

Reference; Test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• There were no deviations in this regard.

You may not qualify if:

• History of hypersensitivity to famotidine and/or related group of drugs, including hypersensitivity to H2 blockers.
• The subject had evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Investigations with blood samples of the subject showed presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
• Investigations with blood samples of the subject showed the presence of values which are 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)
• Investigations with blood samples of the subject showed the presence of values which are 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.
• Investigations with urine samples of the subject 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).
• 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 may 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.
• Use of 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, would have donated and/or lost more than 350 mL of blood in the past 3 months.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited

Noida, Uttar Pradesh, India

Location

Related Links

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MeSH Terms

Interventions

Famotidine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: March 2, 2010
• Study Start: November 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 2, 2010

Record last verified: 2010-03

Locations

IN (1)