Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-24 @ 12:34 PM
NCT ID:
NCT06502561
Brief Summary:
This is 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
Detailed Description:
A single center, 3-period, open-label, crossover study in healthy male and female volunteers who will receive 2 single doses of Aramchol meglumine and 1 single dose of Aramchol free acid under fasting conditions. A single 400 mg dose of Aramchol meglumine (Test 1) will be administered to all study subjects in Period 1. The second dose of Aramchol meglumine will be between 200 mg and 800 mg and will be selected after review of the pharmacokinetics (PK) from Period 1. In Periods 2 and 3, study subjects will be randomized 1:1 to receive the second dose of Aramchol meglumine (Test 2) in one period and a 300 mg tablet of Aramchol free acid (Reference) in the other period. Each product will be given under fasting conditions. The study periods will be separated by a wash-out period of at least 14 days.
Study:
NCT06502561
Study Brief:
Protocol Section:
NCT06502561