Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine

Summary

Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole administered alone \& in combination with MMX® Mesalazine/mesalamine

Timeline

Start

2011-08-22

Primary completion

2011-10-05

Completion

2011-10-05

Outcome

Met primary endpoint

paper fell within the predefined equivalence range (0.80-1.25). PMID 24868146 ↗

registry Geometric Mean ratio 0.979 (90% CI 0.961 to 0.998) NCT01418365 ↗

registry Geometric Mean Ratio 0.993 (90% CI 0.951 to 1.04) NCT01418365 ↗

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	—
Subject	Metronidazole	Small molecule	750 mg	Oral

Indications

No indication recorded.