NCT01442688

Amoxicillin Drug Interaction Study With MMX® Mesalazine/Mesalamine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (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 amoxicillin administered alone \& in combination with MMX Mesalazine/mesalamine.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amoxicillin + MMX placebo	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.
DRUG	Amoxicillin + MMX mesalazine/mesalamine	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.

Timeline

• Start date: 2011-10-07
• Primary completion: 2011-11-20
• Completion: 2011-11-20
• First posted: 2011-09-28
• Last updated: 2021-06-09
• Results posted: 2012-09-14

Locations

1 site across 1 country: United States