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

This study has been completed.

Sponsored by:	Perrigo Company
Information provided by:	Perrigo Company
ClinicalTrials.gov Identifier:	NCT00802451

Purpose

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.

Condition	Intervention
Bioavailability	Drug: Mesalamine

Drug Information available for: Mesalamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study
Official Title:	A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 ml Rectal Enema Formulations

Further study details as provided by Perrigo Company:

Primary Outcome Measures:

Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	February 2003
Study Completion Date:	March 2003
Primary Completion Date:	March 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test Drug: Active Comparator	Drug: Mesalamine
Reference Drug: Active Comparator	Drug: Mesalamine

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Perrigo Company ( Linda Gans )
Study ID Numbers:	10216928
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00802451
Health Authority:	United States: Institutional Review Board

Keywords provided by Perrigo Company:

Bioavailability
Mesalamine

Study placed in the following topic categories:

Mesalamine

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal

Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009