This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
HRS-8080 tablet, specified dose on specified days.
Itraconazole capsule, specified dose on specified days.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Maximum concentration (Cmax) of HRS-8080.
Time frame: From Day 1 to Day 11.
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) of HRS-8080.
Time frame: From Day 1 to Day 11.
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.
Time frame: From Day 1 to Day 11.
Time to maximum plasma concentration (Tmax) of HRS-8080.
Time frame: From Day 1 to Day 11.
Terminal elimination half-life (t1/2) of HRS-8080.
Time frame: From Day 1 to Day 11.
Apparent volume of distribution (Vz/F) of HRS-8080.
Time frame: From Day 1 to Day 11.
Clearance (CL/F) of HRS-8080.
Time frame: From Day 1 to Day 11.
Adverse events (AEs).
Time frame: From Day 1 to Day 17.
Serious adverse events (SAEs).
Time frame: From Day 1 to Day 17.
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