NCT01079065

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

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Famotidine 20 mg Tablets of OHM Laboratories (a Subsidiary of Ranbaxy Pharmaceutical Inc.) With PEPCID AC Tablets (Containing Famotidine 20 mg) of Johnson & Johnson Merck Consumer Pharmaceutical Co. in Healthy, Adult, Human, Male Subjects Under Fasting Condition.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Following an overnight fast of at least 10 hour, a single oral dose of famotidine tablets, USP 20 mg or Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg) was administered during each period of the study, along with 240 mL of drinking water at ambient temperature and under supervision of trained study personnel. During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study for all the subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Famotidine	Tablets

Timeline

• Start date: 2007-11-01
• Primary completion: 2007-11-01
• Completion: 2007-12-01
• First posted: 2010-03-02
• Last updated: 2010-03-02

Locations

1 site across 1 country: India