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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00802451

Enrollment

Registered

2008-12-05

Start date

2003-02-28

Completion date

2003-03-31

Last updated

2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Bioavailability, Mesalamine

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.

Interventions

DRUGMesalamine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026