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

• Sponsor: Padagis LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00802451
• Collaborator: (none)
• Enrollment: 48
• Arms: 2
• Duration (Days): 28

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Mesalamine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Mar 1, 2003
• Actual Study Completion Date: Mar 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Test Drug	Drug: Mesalamine
Active Comparator: Reference Drug	Drug: Mesalamine

Outcome Measures

Primary Outcome Measures

1. Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Padagis LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Padagis LLC
• ClinicalTrials.gov Identifier: NCT00802451
• Other Study ID Numbers: 10216928
• First Posted: Dec 5, 2008
• Last Update Posted: Oct 15, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Padagis LLC: Bioavailability; Mesalamine
• Additional relevant MeSH terms: Mesalamine

Study Results

No Results Posted as of Oct 15, 2021