Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

Phase 1 Completed 44 enrolled Shire

RandomizedCrossoverOpen-labelTreatment

Summary

This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone \& in combination with Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).

Timeline

Start: 2011-11-07
Primary completion: 2011-12-20
Completion: 2011-12-20

Publications

Pierce D, Corcoran M, Martin P, Barrett K, Inglis S, Preston P, Thompson TN, Willsie SK. Effect of MMX(R) mesalamine coadministration on the pharmacokinetics of amoxicillin, ciprofloxacin XR, metronidazole, and sulfamethoxazole: results from four randomized clinical trials. Drug Des Devel Ther. 2014 May 14;8:529-43. doi: 10.2147/DDDT.S55373. eCollection 2014.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesalamine	Small molecule	4.8 g	Oral
Subject	Sulfamethoxazole	Small molecule	800 mg	Oral
Background	Trimethoprim	Small molecule	160 mg	Oral

Indications

No indication recorded.