Status:
COMPLETED
Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
Lead Sponsor:
Padagis LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the reference formulation in healthy, adult subjects.
Eligibility Criteria
Inclusion
- healthy men or women, 18 to 55 years of age
- weight within +/- 25% for height and weight for body frame
- willing to participate and sign a copy of the informed consent form
Exclusion
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- history of allergic response to mesalamine
- evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
- receipt of any drugs as part of a research study within 28 days prior to study dosing
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00802451
Start Date
February 1 2003
End Date
March 1 2003
Last Update
October 15 2021
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