NCT01402947

Ciprofloxacin XR Drug Interaction Study With MMX® Mesalazine/Mesalamine

A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Ciprofloxacin XR Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ciprofloxacin XR + MMX Placebo	MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
DRUG	MMX Mesalazine/mesalamine + Ciprofloxacin XR	MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4

Timeline

• Start date: 2011-07-25
• Primary completion: 2011-08-30
• Completion: 2011-08-30
• First posted: 2011-07-26
• Last updated: 2021-06-09
• Results posted: 2012-07-06

Locations

1 site across 1 country: United States