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Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions

Sponsor
Dr. Reddy's Laboratories Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT01511731
Collaborator
(none)
30
Enrollment
1
Location
2
Arms

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Oct 1, 1998
Actual Primary Completion Date :
Oct 1, 1998
Actual Study Completion Date :
Oct 1, 1998

Arms and Interventions

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.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Clinical Research Center Montreal Canada

    Sponsors and Collaborators

    • Dr. Reddy's Laboratories Limited

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Reddy's Laboratories Limited
    ClinicalTrials.gov Identifier:
    NCT01511731
    Other Study ID Numbers:
    • 981325
    First Posted:
    Jan 19, 2012
    Last Update Posted:
    Jan 19, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Dr. Reddy's Laboratories Limited
    Bioequivalence
    famotidine
    Crossover
    Additional relevant MeSH terms:
    Famotidine

    Study Results

    No Results Posted as of Jan 19, 2012