Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06502561
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None