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Comparison of Aramchol Concentrations With Once or Twice Daily Dosing

Healthy Clinical Trial

Official title:
A Randomised, Open-label Study to Compare Plasma Concentrations of Aramchol in Healthy Volunteers After Once or Twice Daily Oral Dosing to Steady State

Clinical Trial Summary

The trial is an open-label, 2-period, randomised, crossover study of the plasma concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg twice daily and 600 mg once daily.

Clinical Trial Description

The trial is an open-label, 2-period, randomised, crossover study of the plasma concentrations of aramchol, in which subjects will receive oral doses of aramchol at 300 mg twice daily (every 12 h) for 9 days in one period, with a single dose in the morning of Day 10, and 600 mg once daily (every 24 h) for 10 days in the other period. A pharmacokinetic profile will be obtained over the dosing interval on Day 10 of each period.

Enrolment of 16 subjects is planned with each subject taking part in the 2 study periods. The subjects will be randomised 1:1 so that 8 subjects receive each regimen in the first period and the alternate regimen in the second period.

Subjects will be screened within 21 days before their first dose of study medicine. In each period they will remain resident on the ward from Day -1 until the morning of Day 11. Subjects will attend a follow-up visit 14 days (±2 days) after the end of the second period. There will be an interval of at least 7 days between Periods 1 and 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03774173
Study type Interventional
Source Galmed Pharmaceuticals Ltd
Contact
Status Completed
Phase Phase 1
Start date December 8, 2018
Completion date March 5, 2019
View Details
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