CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled / 16 target
Drug / intervention
Aramchol meglumine +1 moredrug
Likely dose
400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06502561
NCT06502561Phase 1CompletedOn Track (1.0/mo)Completion was 12mo ago

A Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine Granules For Oral Suspension To Aramchol Free Acid 300 mg Tablets In Healthy Volunteers

Galmed Pharmaceuticals Ltd·interventional·Posted Jul 16, 2024·Updated Jun 1, 2026

In Brief

A Phase 1 clinical trial evaluating Aramchol meglumine and Aramchol free acid for Healthy. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This is a Phase 1 Relative Bioavailability Study Comparing The Pharmacokinetics Of Aramchol Meglumine (AM) Granules For Oral Suspension To Aramchol Free Acid (AA) 300 mg Tablets In Healthy Volunteers

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBulgaria
Collaborators--

Timeline

Phase 1CompletedFinished
20252026
First PostedJul 16, 2024
Enrollment StartFeb 15, 2025
Primary CompletionJun 15, 2025
Study CompletionNov 17, 2025
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 2.0 years ago

Arms & Interventions

Subjects receiving a single 400 mg dose of Aramchol meglumine in Period 1experimental

A single 400 mg dose of Aramchol meglumine will be administered to all study subjects in Period 1.

Drug: Aramchol meglumine
Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 2active_comparator

In Period 2, study subjects will be randomized 1:1 to receive Aramchol meglumine or 300 mg tablet of Aramchol free acid (Reference)

Drug: Aramchol meglumineDrug: Aramchol free acid
Subjects receiving a second dose of Aramchol meglumine or Aramchol free acid in Period 3active_comparator

In Period 3, study subjects will be randomized 1:1 to receive Aramchol meglumine or 300 mg tablet of Aramchol free acid (Reference)

Drug: Aramchol meglumineDrug: Aramchol free acid

Interventions

Aramchol megluminedrug

Aramchol meglumine is a salt form of Aramchol free acid

Aramchol free aciddrug

Aramchol free acid is a fatty acid-bile acid conjugate