Sulfamethoxazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

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

Outcome

Met primary endpoint

paper increased exposure (by 12% in Cmax at steady state; by 15% in AUC at steady state) was not considered clinically significant PMID 24868146 ↗

paper the 90% CIs for each point estimate fell entirely within the predefined equivalence range. PMID 24868146 ↗

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.