NCT00840203

Mesalamine 4 gm/60 mL Rectal Enema

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Rowasa® 4 gm/60 mL Rectal Enema	1 x 4 gm/60 mL, single-dose
DRUG	Mesalamine 4 gm/60 mL Rectal Enema	1 x 4 gm/60 mL, single-dose

Timeline

• Start date: 2003-05-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2009-02-10
• Last updated: 2024-08-19
• Results posted: 2009-08-04

Locations

1 site across 1 country: United States