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

Study Overview
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Brief Summary
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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
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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

Conditions
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Heartburn

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Famotidine/antacid combination tablet with water | Drug: famotidine (+) calcium carbonate (+) magnesium hydroxide tablet<br>* A single dose of famotidine/antacid tablet with 120 mL of water in one of three treatment periods<br>|
| Experimental: B<br>Famotidine/Antacid EZ Chew tablet without water | Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water<br>* A single dose of famotidine/antacid combination EZ Chew tablet without water in one of three treatment periods<br>|
| Experimental: C<br>Famotidine/Antacid EZ Chew tablet with water | Drug: Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water<br>* A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) |