Bioavailability Study of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations
- 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
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
- Secondary Outcome Measures
Name Time Method