Status:
COMPLETED
A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Heartburn
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00944671
Start Date
February 1 2008
End Date
March 1 2008
Last Update
June 24 2015
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