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Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT01511731
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Famotidine Drug: Pepcid Phase 1

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 1998
Actual Primary Completion Date : October 1998
Actual Study Completion Date : October 1998

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Famotidine
Famotidine tablets 40 mg of Dr. Reddy's
Drug: Famotidine
Famotidine Tablets 40 mg
Other Name: Reddy Cheminor
Active Comparator: Pepcid
Pepcid 40 mg Tablets of Merck & Co.,
Drug: Pepcid
40mg tablets
Other Name: Merck & Co.



Primary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511731


Locations
Canada
Phoenix Clinical Research Center
Montreal, Canada
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Samuel Serfaty, MD Phoenix Clinical Research Center

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01511731     History of Changes
Other Study ID Numbers: 981325
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
famotidine
Crossover

Additional relevant MeSH terms:
Famotidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs