Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360055
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-15
Brief Title:
Effect of Oral D-mannose Tablets on Pharmacokinetics of Dabigatranate in Healthy Adults
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
A Prospective Single-Center Open-Label Study of the Effect of Oral D-mannose Tablets on the Pharmacokinetics of Dabigatran Etexilate in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to investigate the effects of oral D-mannose tablets for 2 consecutive weeks on the pharmacokinetics of dabigatrun etexilate a P-glycoprotein probe substrate drug in healthy adults
Detailed Description:
This study is a prospective sinale-center open-label clinical studly with adult healthy subiects as the research subjects Healthy adult subjects will receive a single oral dose of 110mg low dose specification in the instructions or lower of dabigatran etexilate on day 1 and day 16 of the trial period Blood samples for dabigatran plasma concentration determination at 0 hbefore dosing2 h 4 h 6 h 12 h and 24 h after dosing will be taken Subjects will take 3g 1g3 tablets of D-mannose tablets every morning and evening from the 2nd day to the 15th day of the trial period with a total of 6gday medium dose specification in the instructions Blood samples for detection of glycotomic serum concentrations such as D-mannose will be taken 0h before oral administration of dabigatran etexilate on day 1 and 15h after oral administration of D-mannose each morning on days 2 8 and 15 of the trial period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None