Trial Profile

Bioequivalence study of aramchol

Status: Planning

Phase of Trial: Phase II

Latest Information Update: 13 Aug 2020

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At a glance

Drugs Icomidocholic acid (Primary)
Indications Non-alcoholic steatohepatitis
Focus Pharmacokinetics
Sponsors Galmed Pharmaceuticals

Most Recent Events

13 Aug 2020 New trial record
06 Aug 2020 According to a Galmed Pharmaceuticals media release, a preliminary bioequivalence (BE) study is planned for the third quarter of 2021 this year for identifying the equivalent dose to 300mg BID of aramchol acid. This study is intended to serve as calibration for the regulatory BE study that Galmed plans on performing during the second quarter of 2021 with the identified Aramchol meglumine dose.

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