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
1 other identifier
interventional
48
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Feb 2003
Shorter than P25 for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedOctober 15, 2021
October 1, 2021
28 days
December 4, 2008
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
Study Arms (2)
Test Drug
ACTIVE COMPARATORReference Drug
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Padagis LLClead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
February 1, 2003
Primary Completion
March 1, 2003
Study Completion
March 1, 2003
Last Updated
October 15, 2021
Record last verified: 2021-10