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Completed

NCT Number: NCT00802451

Bioavailability Study 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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mesalamine

Drug

Primary outcomes

  1. Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity

Sponsors and collaborators

Lead sponsor

Padagis LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Dec 5, 2008
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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