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

NCT00802451 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-10-15

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Mesalamine

Sponsors & Collaborators

  • Padagis LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2003-03-31
Completion
2003-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00802451 on ClinicalTrials.gov