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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

Trial Profile

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 of Trial: Phase I

Latest Information Update: 27 Jul 2020

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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

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