The purpose of this study is to evaluate the effect of food on the PK of a single dose of 52.5 mg Hemay005 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Cmax
Maximum observed plasma concentration
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Tmax
Time of maximum concentration
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
AUCt
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
AUC∞
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
t1/2
Terminal elimination half-life
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
CL/F
Apparent total plasma clearance
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 ,72hours post-dose on day 1 and day 8
Number of participants with adverse events, serious adverse events
Time frame: Day 1 up to Day 11±3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.