At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 72 enrolled
Drug / intervention
Rowasa® 4 gm/60 mL Rectal Enema +1 moredrug
Likely dose
Rowasa® 4 gm/60 mL Rectal Enemafrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 mL Rectal Enema Formulations
In Brief
A Phase 1 clinical trial evaluating Rowasa® 4 gm/60 mL Rectal Enema and Mesalamine 4 gm/60 mL Rectal Enema for Healthy. Completed, enrolled 72 participants across 1 site.
Detailed Summary
The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2003
Primary CompletionJun 2003
First PostedFeb 2009
TodayJul 2026
First PostedFeb 10, 2009
Enrollment StartMay 1, 2003
Primary CompletionJun 1, 2003
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.4 years ago
Interventions
Rowasa® 4 gm/60 mL Rectal Enemadrug
1 x 4 gm/60 mL, single-dose
Mesalamine 4 gm/60 mL Rectal Enemadrug
1 x 4 gm/60 mL, single-dose