CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
sulfamethoxazole + MMX placebo +1 moredrug
Likely dose
sulfamethoxazole + MMX placebo 800 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/NCT01469637
NCT01469637Phase 1Completed
CompareCT.gov

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

Shire·interventional·Posted Nov 10, 2011·Updated Jul 13, 2021

In Brief

A Phase 1 clinical trial evaluating sulfamethoxazole + MMX placebo and Sulfamethoxazole + MMX Mesalazine/mesalamine for Healthy. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This is a drug interaction study evaluating the pharmacokinetic profiles of Sulfamethoxazole administered alone \& in combination with Multi MatriX system (MMX®) formulation of mesalazine/mesalazine (Lialda®; Mesavancol®; Mezavant®) (MMX Mesalazine/mesalamine).

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartNov 7, 2011
Primary CompletionDec 20, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.6 years ago

Interventions

sulfamethoxazole + MMX placebodrug

800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX Mesalazine/mesalamine placebo once daily (QD) orally for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX Mesalazine/mesalamine placebo orally on Day 4.

Sulfamethoxazole + MMX Mesalazine/mesalaminedrug

800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4