At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 30 enrolled

Drug / intervention

Metronidazole + MMX Mesalazine/mesalamine placebo +1 moredrug

Likely dose

Metronidazole + MMX Mesalazine/mesalamine placebo 750 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/NCT01418365

NCT01418365Phase 1Completed

Compare CT.gov

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

Shire·interventional·Posted Aug 17, 2011·Updated Jun 9, 2021

In Brief

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

Detailed Summary

Drug interaction study evaluating the pharmacokinetic profiles of Metronidazole 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 PostedAug 2011

Enrollment StartAug 2011

Primary CompletionOct 2011

TodayJul 2026

First PostedAug 17, 2011

Enrollment StartAug 22, 2011

Primary CompletionOct 5, 2011

TodayJul 2, 2026

Enrollment to primary: 1 monthPosted 14.9 years ago

Interventions

Metronidazole + MMX Mesalazine/mesalamine placebodrug

Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine placebo single dose on Day 4 orally

Metronidazole + MMX Mesalazine/mesalaminedrug

Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally