Status:
COMPLETED
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Heartburn
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration...
Eligibility Criteria
Inclusion
- Female participant is not pregnant or lactating
- Female of childbearing potential must use reliable means of contraception during the course of the study
- Is in good health
- Is able to abstain from smoking during the 24-hour periods before and during each treatment day
Exclusion
- Has any major systemic disorders
- Has a history of ulcers, other Gastrointestinal (GI) disease, or GI surgery
- Has or has a history of any illness or condition that might interfere with optimal participation in the study
- Has a history of asthma or severe allergies to drugs or foods
- Currently uses prescribed or non-prescribed drugs on a regular basis
- Has a recent history of drug/alcohol abuse
- Consumes more than 6 cups of coffee per day
- Has unconventional or extreme dietary habits
- Has donated blood or has been in a clinical trial in which they received an investigational drug during the past 30 days
- Has a history of allergy or intolerance to antacids
- Is known to be pregnant or is not using reliable means of contraception
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00945750
Start Date
August 1 2006
End Date
September 1 2006
Last Update
March 10 2017
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