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Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Information source: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Famotidine (Drug); Pepcid (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Dr. Reddy's Laboratories Limited

Official(s) and/or principal investigator(s):
Samuel Serfaty, MD, Principal Investigator, Affiliation: Phoenix Clinical Research Center


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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area Under Curve (AUC)

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.


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.


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.

Locations and Contacts

Phoenix Clinical Research Center, Montreal, Canada
Additional Information

Starting date: October 1998
Last updated: January 18, 2012

Page last updated: August 23, 2015

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