At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 62 enrolled
Drug / intervention
Amoxicillin + MMX placebo +1 moredrug
Likely dose
Amoxicillin + 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.
A Phase 1, Randomized, Open-label, Crossover, Drug Interaction Study Evaluating the Pharmacokinetic Profiles of Amoxicillin Administered Alone and in Combination With MMX® Mesalazine/Mesalamine in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating Amoxicillin + MMX placebo and Amoxicillin + MMX mesalazine/mesalamine for Healthy. Completed, enrolled 62 participants across 1 site.
Detailed Summary
This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin 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 PostedSep 2011
Enrollment StartOct 2011
Primary CompletionNov 2011
TodayJul 2026
First PostedSep 28, 2011
Enrollment StartOct 7, 2011
Primary CompletionNov 20, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.8 years ago
Interventions
Amoxicillin + MMX placebodrug
MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
Amoxicillin + MMX mesalazine/mesalaminedrug
MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.