Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00945750
First received: July 22, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

This study will determine whether the chewable tablet (CT) formulation of famotidine taken with and without water is bioequivalent to the film coated tablet (FCT) formulation.


Condition Intervention Phase
Heartburn
Drug: famotidine film-coated tablet (FCT)
Drug: Comparator: famotidine chewable tablet (CT)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Dose, Open-Label, Three-Period Crossover Study to Assess the Bioequivalence of Famotidine 20 mg Film-Coated Tablets Compared to Famotidine 20 mg Chewable Tablets (CT) Without Water and Famotidine 20 mg CT With Water

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area under the curve (AUC(0 to infinity)) following single dose administration of famotidine CT without water and famotidine FCT with water [ Time Frame: Through 24 hours postdose ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) of famotidine following single dose administration of famotidine CT without water and famotidine FCT with water [ Time Frame: Through 24 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve (AUC(0 to infinity)) following single dose administration of famotidine CT with water and famotidine FCT with water [ Time Frame: Through 24 hours postdose ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) of famotidine following single dose administration of famotidine CT with water and famotidine FCT with water [ Time Frame: Through 24 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Famotidine 20-mg FCT
Drug: famotidine film-coated tablet (FCT)
Single dose of famotidine 20 mg FCT with 120 mL water in one of three treatment periods
Experimental: B
Famotidine chewable tablet (CT) without water
Drug: Comparator: famotidine chewable tablet (CT)
Single dose of famotidine 20 mg CT without water in one of three treatment periods
Experimental: C
Famotidine CT with water
Drug: Comparator: famotidine chewable tablet (CT)
Single dose of famotidine 20 mg CT with 120 mL water in one of three treatment periods

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female subject is not pregnant or lactating
  • Females of childbearing potential must use reliable means of contraception during the course of the study
  • Subject is in good health
  • Subject is able to abstain from smoking during the 24-hour periods before and during each treatment day

Exclusion Criteria:

  • Subject has any major systemic disorders
  • Subject has a history of ulcers, other GI disease, or GI surgery
  • Subject has or has a history of any illness or condition that might interfere with optimal participation in the study
  • Subject has a history of asthma or severe allergies to drugs or foods
  • Subject currently uses prescribed or nonprescribed drugs on a regular basis
  • Subject has a recent history of drug/alcohol abuse
  • Subject consumes more than 6 cups of coffee per day
  • Subject has unconventional or extreme dietary habits
  • Subject has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
  • Subject has a history of allergy or intolerance to antacids
  • Female subject is known to be pregnant or is not using reliable means of contraception
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00945750

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00945750     History of Changes
Other Study ID Numbers: 2009_621, MK0208-144
Study First Received: July 22, 2009
Last Updated: July 22, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014