The main purpose of this study is to evaluate the effect of formulation on relative bioavailability of HDM1002, and the food effect on pharmacokinetics of HDM1002.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Single dose, administered orally. The study is a randomized, open-label, single dose, 3-period, 3 sequence, crossover design.
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
AUC[0-∞]
Area under the curve from time 0 hour to ∞
Time frame: Day1-Day17
AUC[0-t]
Area under the curve from time 0 to t hour
Time frame: Day1-Day17
Cmax
Maximum observed concentration
Time frame: Day1-Day17
Tmax
Time to maximum plasma concentration
Time frame: Day1-Day17
t1/2
Half life
Time frame: Day1-Day17
CL/F
Apparent Clearance
Time frame: Day1-Day17
Vz/F
Apparent volume of distribution
Time frame: Day1-Day17
F
Relative Bioavailability
Time frame: Day1-Day17
Adverse events (AEs)
Number of subjects reporting AEs
Time frame: Day1-Day17
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