CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
famotidine (+) calcium carbonate (+) magnesium hydroxide tablet +2 moredrug
Likely dose
famotidine (+) calcium carbonate (+) magnesium hydroxide tablet 120 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00944671
NCT00944671Phase 1Completed
CompareCT.gov

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

Johnson & Johnson Consumer and Personal Products Worldwide·interventional·Posted Jul 23, 2009·Updated Jun 24, 2015

In Brief

A Phase 1 clinical trial evaluating famotidine (+) calcium carbonate (+) magnesium hydroxide tablet, Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water, and 1 other intervention for Heartburn. Completed, enrolled 24 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeartburn
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 23, 2009
Enrollment StartFeb 1, 2008
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago

Interventions

famotidine (+) calcium carbonate (+) magnesium hydroxide tabletdrug

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 waterdrug

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 waterdrug

A single dose of famotidine/antacid combination EZ Chew tablet with 120 mL of water in one of three treatment periods