NCT00944671

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heartburn

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2009-07-23
• Last updated: 2015-06-24
• Results posted: 2015-06-24