Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine

Phase 1 Completed 30 enrolled Shire

RandomizedCrossoverOpen-labelTreatment

Summary

This is a drug interaction study evaluating the pharmacokinetic profiles of Ciprofloxacin XR administered alone \& in combination with MMX Mesalazine/mesalamine.

Timeline

Start: 2011-07-25
Primary completion: 2011-08-30
Completion: 2011-08-30

Outcome

Met primary endpoint

paper for maximum plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) fell within the predefined equivalence range (0.80-1.25). PMID 24868146 ↗

registry Geometric Mean Ratio 1.013 (90% CI 0.933 to 1.100) NCT01402947 ↗

registry Geometric Mean Ratio 0.999 (90% CI 0.893 to 1.117) NCT01402947 ↗

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	Ciprofloxacin	Small molecule	500 mg	Oral
Subject	Mesalamine	Small molecule	4.8 g	Oral

Indications

No indication recorded.