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

Condition(s) targeted: Heartburn

Intervention: 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 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Johnson & Johnson Consumer and Personal Products Worldwide

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew Without Water and Famotidine/Antacid Tablet With Water

Secondary outcome:

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

Peak Plasma Concentration (Cmax) of Famotidine Following Single Dose Administration of Famotidine/Antacid Combination EZ Chew With Water and Famotidine/Antacid Tablet With Water

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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 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

MedWatch - FDA maintained medical product safety Information

Merck: Patient & Caregiver U.S. Product Web Site

Starting date: February 2008
Last updated: June 19, 2015