A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00944671

Purpose

A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water. Subjects will be given a single dose of each treatment separated by 5 to 7 days.

Condition	Intervention	Phase
Heartburn	Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water	Phase I

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/Antacid Combination Tablets (FACT) Compared to Famotidine/Antacid EZ Chew Tablet Without Water and Famotidine/Antacid EZ Chew Tablet With Water

Resource links provided by NLM:

MedlinePlus related topics: Calcium Heartburn

Drug Information available for: Magnesium hydroxide Famotidine Calcium gluconate Calcium carbonate Magnesium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Area under the curve (AUC(0 to infinity)) following single dose administration of famotidine/antacid combination EZ Chew without water and famotidine/antacid tablet with water [ Time Frame: Through 24 hours post dose ] [ Designated as safety issue: No ]
Peak plasma concentration (Cmax) of famotidine following single dose administration of famotidine/antacid combination EZ Chew without water and famotidine/antacid tablet with water [ Time Frame: Through 24 hours post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Area under the curve (AUC(0 to infinity)) following single dose administration of famotidine/antacid combination EZ Chew with water and famotidine/antacid tablet with water [ Time Frame: Through 24 hours post dose ] [ Designated as safety issue: No ]
Peak plasma combination (Cmax) of famotidine following single dose administration of famotidine/antacid combination EZ Chew with water and famotidine/antacid tablet with water [ Time Frame: Through 24 hours post dose ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	February 2008
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Famotidine/Antacid Chewable tablet with water	Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods
Experimental: B Famotidine/Antacid EZ Chew tablet without water	Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods
Experimental: C Famotidine/Antacid EZ Chew tablet with water	Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of 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 a history of stomach ulcers, other GI diseases or GI surgery
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944671

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00944671 History of Changes
Other Study ID Numbers:	2009_622, MK0208C-145
Study First Received:	July 22, 2009
Last Updated:	July 22, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Antacids
Calcium Carbonate
Magnesium Hydroxide
Calcium, Dietary
Famotidine
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Bone Density Conservation Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012