This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Specified dose on specified days.
Specified dose on specified days.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeak concentration (Cmax)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Time to reach peak concentration (Tmax)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Elimination half-life (t1/2)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Apparent clearance (CL/F)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
Apparent volume of distribution (Vz/F)
Time frame: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
The incidence and severity of any adverse events (AEs)
Time frame: From Day 1 to Day 29 in part 1, from Day 1 to Day 21 in part 2.
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