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

A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

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.

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