A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)

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

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.

Study Overview

• Status: Completed
• Conditions: Heartburn
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Gastrointestinal (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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Famotidine/antacid combination 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water	Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)
Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water	Through 24 hours post-dose (½, 1, 1 ½, 2, 2 ½, 3, 4, 6, 8, 10, 12, 14, 24 hours post-dose)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: July 22, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 19, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Antacids; Histamine H2 Antagonists; Calcium; Calcium, Dietary; Calcium Carbonate; Magnesium Hydroxide; Famotidine
• Other Study ID Numbers: 0208C-145; 2009_622

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No