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

Heartburn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944671
• Other study ID #: 0208C-145
• Secondary ID: 2009_622
• Status: Completed
• Phase: Phase 1
• First received: July 22, 2009
• Last updated: June 19, 2015
• Start date: February 2008
• Est. completion date: March 2008

Study information

• Verified date: June 2015
• Source: Johnson & Johnson Consumer and Personal Products Worldwide
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Heartburn

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Consumer and Personal Products Worldwide

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site