NCT00751699

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

A Randomized, Open-label, Multiple Dose, Parallel Group Study to Evaluate 5 ASA and N Ac 5 ASA Pharmacokinetics Following Administration of Oral Doses of Asacol 2.4 g/Day and Lialda 2.4 g/Day for 7 Days in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Asacol	Asacol tablets, 6 tablets per day at 7 am for 7 days
DRUG	Asacol	Asacol tablets, 400 mg, 2 tablets at 7 am, 3 pm, and 11 pm for 7 days
DRUG	Lialda	Lialda tablets 1.2 g, 2 tablets once a day at 7 am for 7 days

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2008-09-12
• Last updated: 2013-04-17

Locations

1 site across 1 country: United States