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

NCT00944671 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-06-24

Study results available
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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

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

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-03-31
Completion
2008-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00944671 on ClinicalTrials.gov