CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Ciprofloxacin XR + MMX Placebo +1 moredrug
Likely dose
Ciprofloxacin XR + MMX Placebo 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01402947
NCT01402947Phase 1Completed
CompareCT.gov

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

Shire·interventional·Posted Jul 26, 2011·Updated Jun 9, 2021

In Brief

A Phase 1 clinical trial evaluating Ciprofloxacin XR + MMX Placebo and MMX Mesalazine/mesalamine + Ciprofloxacin XR for Healthy. Completed, enrolled 30 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2011
Enrollment StartJul 25, 2011
Primary CompletionAug 30, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.9 years ago

Interventions

Ciprofloxacin XR + MMX Placebodrug

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

MMX Mesalazine/mesalamine + Ciprofloxacin XRdrug

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