Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Mesalamine

• Registration Number: NCT00802451
• Lead Sponsor: Padagis LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Drug	Mesalamine	-
Reference Drug	Mesalamine	-

Primary Outcome Measures

Name	Time	Method
Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity