Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

January 18, 2012 updated by: Dr. Reddy's Laboratories Limited

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
        • Phoenix Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Famotidine
Famotidine tablets 40 mg of Dr. Reddy's
Drug: Famotidine
Famotidine Tablets 40 mg
Other Names:
  • Reddy Cheminor
ACTIVE_COMPARATOR: Pepcid
Pepcid 40 mg Tablets of Merck & Co.,
Drug: Pepcid
40mg tablets
Other Names:
  • Merck & Co.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Reddy's Laboratories Limited

Investigators

  • Principal Investigator: Samuel Serfaty, MD, Phoenix Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1998

Primary Completion (ACTUAL)

October 1, 1998

Study Completion (ACTUAL)

October 1, 1998

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 18, 2012

First Posted (ESTIMATE)

January 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 981325

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Famotidine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe