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
Latest Information Update: 27 Jul 2020
At a glance
- Drugs Mesalazine (Primary) ; Mesalazine (Primary)
- Indications Crohn's disease; Inflammatory bowel diseases; Irritable bowel syndrome; Proctitis; Ulcerative colitis
- Focus Pharmacokinetics
- Sponsors Warner Chilcott
Most Recent Events
- 27 Jul 2020 New trial record
- 15 Jul 2020 Primary endpoint (Pharmacokinetic endpoints of primary interest include AUC24 and the amount of 5-ASA excreted in the urine by subjects dosed with Asacol and Lialda)has not been met.
- 15 Jul 2020 Results published in the British Journal of Clinical Pharmacology