Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for AmoxicillinPrimary· Assessed over a 24-hour period starting post-dose on day 4
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Group
Value
95% CI
Amoxicillin + MMX Placebo
27.8
± 5.02
Amoxicillin + MMX Mesalazine/Mesalamine
28.3
± 6.37
Maximum Plasma Concentration (Cmax) for AmoxicillinPrimary· Assessed over a 24-hour period starting post-dose on day 4
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Group
Value
95% CI
Amoxicillin + MMX Placebo
10.3
± 2.59
Amoxicillin + MMX Mesalazine/Mesalamine
10.2
± 2.89
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a drug interaction study evaluating the pharmacokinetic profiles of amoxicillin administered alone \& in combination with MMX Mesalazine/mesalamine.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 9 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01442688.