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Clinical Trial Summary

This is a phase I, open-label, fixed design, drug-drug-interaction (DDI) study divided in 2 parts. Part I is designed to evaluate whether concomitant treatment with linaprazan glurate and clarithromycin, a strong inhibitor of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein P (PgP), leads to an effect on the systemic exposure to linaprazan glurate and linaprazan and whether there is an effect on the pharmacokinetics of clarithromycin after a single dose of linaprazan glurate. Part II is designed to evaluate the effect of repeated doses of linaprazan glurate on the pharmacokinetics (PK) of a sensitive substrate of CYP3A (midazolam).


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05633147
Study type Interventional
Source Cinclus Pharma Holding AB
Contact
Status Completed
Phase Phase 1
Start date November 27, 2022
Completion date May 30, 2023

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