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

Johnson & Johnson (J&J)

Status and phase: Completed; Phase 1

Conditions: Heartburn

Treatments: 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

Funder types: Industry

Identifiers

NCT00944671

0208C-145

2009_622

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

A

Active Comparator group

Description:

Famotidine/antacid combination tablet with water

Treatment:

Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet

B

Experimental group

Description:

Famotidine/Antacid EZ Chew tablet without water

Treatment:

Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water

C

Experimental group

Description:

Famotidine/Antacid EZ Chew tablet with water

Treatment:

Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water