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

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Padagis LLC; Perrigo Company
• Treatments: Mesalamine

Criteria

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