Overview
Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine tablet.
Description
Evaluate the exposure of of Aramchol from 2 different single doses of Aramchol meglumine tablet and to compare the exposure of steady state from a selected dose of Aramchol meglumine given one daily with that from a 300 mg dose of Aramchol free acid tablets given twice daily in adult Healthy volunteers.
Eligibility
Inclusion Criteria:
- Male or female healthy volunteers with body mass index (BMI) in the range of 18-30.9 kg/ m2 inclusive
- Deemed healthy on the basis of clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
- Agree to follow-up the contraception requirements of the trial
- Able to give fully informed written consent
Exclusion Criteria:
- Females of reproductive potential who are pregnant or lactating
- Positive tests for hepatitis B, C or HIV
- History of sever adverse reaction to any drug
- Known sensitivity to drug medication
- Drug or alcohol abuse
- Smoking in the 3 months prior the study
- Clinically relevant abnormal lab results, medical history or concurrent medical condition
- Evidence of acute or chronic disease
- Inability to adhere to study requirements
