This study is intended to quantify the effect of food on the pharmacokinetics of BPI-16350. Subjects will be randomized to a crossover sequence at a 1:1 ratio and administered the dose of BPI-16350 on Day 1 in Period 1 and on Day 15 in Period 2 under fasting conditions(Treatment A) or with a high-fat meal(Treatment B).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Administered orally
Kthics Committee (seal),of Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Cmax
Maximum observed concentration
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
AUC0-t
Area under the concentration-time curve from time 0 to time t
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
AUC0-∞
Area under the concentration-time curve from time 0 to infinity
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Tmax
Time to reach maximum observed plasma concentration
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
t1/2
Half-life time
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
λz
Elimination rate constant
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
tlag
Lag Time
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
AUC %Extrap
Percentage of AUCinf due to extrapolation from Tlast to infinity
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CL/F
Apparent Oral Clearance
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
V/F
Apparent Volume of Distribution
Time frame: from Day 1 to Day 9 after the first dose and from Day 15 to Day 23 after the second dose
Characterize the safety of BPI-16350
Number of subjects with treatment related adverse events
Time frame: from Day 1 to Day 23