Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers

Phase 1 Completed 37 enrolled Warner Chilcott

RandomizedParallel-groupOpen-label

Summary

This study evaluated pharmacokinetics of 5-ASA and N-Ac-5-ASA associated with each of 3 regimens of oral mesalamine 2.4 g/day (Lialda 2.4 g/day 2 x 1.2 g every 24 hours, Asacol® 6 x 400 mg every 24 hours, or Asacol 2 x 400 mg every 8 hours). Primary endpoints were 5-ASA area under the plasma concentration versus time curve from zero to 24 hours (AUC24) and total 5-ASA percent of dose excreted (A'e \[%\]) over the 24-hour period on Day 7.

Timeline

Start: 2007-03
Primary completion: 2007-04
Completion: 2007-04

Publications

Vande Casteele N, Jakate A, McNamee B, Sandborn WJ. Similar pharmacokinetics of three dosing regimens comprising two oral delayed-release mesalamine formulations in healthy adult volunteers: Randomised, open-label, parallel-group study. Br J Clin Pharmacol. 2021 Mar;87(3):1141-1149. doi: 10.1111/bcp.14479. Epub 2020 Aug 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesalamine	Small molecule	800 mg	—
Subject	Mesalamine	Small molecule	2400 mg	—

Indications

No indication recorded.