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

Padagis

Status: Completed

Conditions: Healthy

Treatments: Drug: Mesalamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802451

10216928

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Test Drug

Active Comparator group

Treatment:

Drug: Mesalamine

Reference Drug

Active Comparator group

Treatment:

Drug: Mesalamine