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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
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.
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).
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGPlasma concentration of dabigatran
Plasma concentration of dabigatran will be measured by liquid chromatography-tandem mass spectrometry
Time frame: 0 hours before and 2, 6, 10 and 24 hours after administration of dabigatran etexilate on the day 1 and day 16 of the trial period.
Serum concentrations of glycoomics such as D-mannose
Serum concentrations of glycoomics such as D-mannose will be measured by gas chromatography-tandem mass spectrometry
Time frame: 0 hours before administration of dabigatran etexilate of day 1 and 1.5 hours after D-mannose administration in the morning of day 2, day 8 and day 15.
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