Pharmacokinetics of Asacol 2.4 g/Day and Lialda 2.4 g/Day in Healthy Volunteers
Status:
Completed
Trial end date:
2007-04-01
Target enrollment:
Participant gender:
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.