Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Famotidine; Drug: Pepcid

• Registration Number: NCT01511731
• Lead Sponsor: Dr. Reddy's Laboratories Limited

Brief Summary

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.

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.

Study Timeline

• Study Start: 1998-10
• Primary Completion: 1998-10
• Study Completion: 1998-10
• Status Verified: 2012-01
• Study First Submitted: 2012-01-12
• Study First Submitted QC: 2012-01-18
• Last Update Submitted: 2012-01-18
• Study First Posted: 2012-01-19
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Famotidine	Famotidine	Famotidine tablets 40 mg of Dr. Reddy's
Pepcid	Pepcid	Pepcid 40 mg Tablets of Merck \& Co.,

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC)	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.

Trial Locations

Locations (1)

Phoenix Clinical Research Center; 🇨🇦 Montreal, Canada