Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 62
Healthy volunteers: yes

Brief summary:
This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin administered alone \& in combination with MMX Mesalazine/mesalamine.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Amoxicillin + MMX placebo intervention 2: Amoxicillin + MMX mesalazine/mesalamine
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: