NCT06360055

Effect of Oral D-mannose Tablets on Pharmacokinetics of Dabigatranate in Healthy Adults

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 h(before dosing)2 h, 4 h, 6 h, 12 h and 24 h after dosing will be taken. Subjects will take 3g (1g\*3 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 6g/day (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 1.5h after oral administration of D-mannose each morning on days 2, 8, and 15 of the trial period.

Conditions

• Health

Interventions

Type	Name	Description
DRUG	Dabigatran Etexilate	Subjects will receive a single oral dose of 110mg (low dose specification in the instructions) or lower of dabigatran etexilate on an empty stomach on the morning of day 1 and day 16 of the trial period.
DIETARY_SUPPLEMENT	D-mannose	Subjects will take 3g (1g\*3 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 6g/day (medium dose specification in the instructions).

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2024-04-11
• Last updated: 2024-04-11

Locations

1 site across 1 country: China