This study is a single-center, open label phase I clinical study to characterize the DDIs potential of ZSP1273 With Warfarin and Midazolam in Chinese healthy participants. This study also aims to evaluate the safety and tolerability of ZSP1273 in the presence of Warfarin and Midazolam.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Drug Warfarin oral Drug midazolam oral
the Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
S-warfarin Maximum Plasma Concentration [Cmax]
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Time frame: Day1 to Day28
Midazolam Maximum Plasma Concentration [Cmax]
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
Time frame: Day1 to Day28
S-warfarin Area under the curve[AUC0-inf]
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of S-warfarin
Time frame: Day1 to Day28
Midazolam Area under the curve[AUC0-inf]
To assess the effect of steady-state ZSP1273 on the pharmacokinetic (PK) of a single dose of midazolam and its active metabolite alpha-hydroxymidazolam
Time frame: Day1 to Day28
Number of participants with adverse events and serious adverse events
To assess the safety and tolerability of ZSP1273 following single and multiple-dose administration with and without midazolamin+S-warfarin in healthy participates
Time frame: Day1 to Day28
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