clinical trial · NCT00840203
Mesalamine 4 gm/60 mL Rectal Enema
Teva Pharmaceuticals USA·phase1·completed·n = 72
HealthyRowasa® 4 gm/60 mL Rectal EnemaMesalamine 4 gm/60 mL Rectal Enema
brief 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.
started
May 1, 2003
primary completion
Jun 1, 2003
completion
Jun 1, 2003
last updated
Aug 19, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Study to Evaluate the Relative Bioavailability of Two Mesalamine 4 gm/60 mL Rectal Enema Formulations
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol