Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Overview

The objective of this study was to compare the single-dose relative bioavailability of Reddy Cheminor and Merck &Co, pepcid 40 mg famotidine tablets under fasting conditions.

Full Title of Study: “Open-label, Randomized, 2-way Crossover Study to Compare the Bioavailability of Reddy Cheminor and Merck &Co, Pepcid Famotidine Tablets 40 mg Under Fasting Conditions.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 1998

Detailed Description

Detailed Description : The study was conducted as an open-label, randomized, single-dose, 2-way crossover, relative bioavailability study performed on 30 healthy adult male volunteers. A total of 30 subjects completed the clinical phase of the study. Single oral 40 mg doses were separated by a washout period of 7 days.

Interventions

  • Drug: Famotidine
    • Famotidine Tablets 40 mg
  • Drug: Pepcid
    • 40mg tablets

Arms, Groups and Cohorts

  • Experimental: Famotidine
    • Famotidine tablets 40 mg of Dr. Reddy’s
  • Active Comparator: Pepcid
    • Pepcid 40 mg Tablets of Merck & Co.,

Clinical Trial Outcome Measures

Primary Measures

  • Area Under Curve (AUC)
    • Time Frame: predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose.

Participating in This Clinical Trial

Inclusion Criteria

Exclusion Criteria:

History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of:

  • alcoholism or drug abuse within the past year; – hypersensitivity or idiosyncratic reaction to famotidine or any other histamine H2-receptor antagonist; Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study. Subjects who, through completion of the study, would have donated in excess of: – 500 mL of blood in 14 days, or – 500 – 750 mL of blood in 14 days (unless approved by the Principal Investigator), – 1000 mL of blood in 90 days, – 1250 mL of blood in 120 days, – 1500 mL of blood in 180 days, – 2000 mL of blood in 270 days, – 2500 mL of blood in 1 year. Subjects who have participated in another clinical trial within 28 days of study start.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Dr. Reddy’s Laboratories Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Samuel Serfaty, MD, Principal Investigator, Phoenix Clinical Research Center

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