The study was a single-center, randomized, open-access, two-crossover, single-dose study design with 16 subjects to evaluate the pharmacokinetics of a high-fat diet on a single dose of oral AD16 tablets in healthy Chinese adults and the safety of a single dose of oral AD16 tablets in healthy Chinese adults. Compared with fasting administration, a high-fat diet reduced the rate of AD16 tablet absorption in healthy adult subjects and had no effect on overall exposure to AD16. The elimination and distribution characteristics of AD16 in vivo were similar under the conditions of feeding and fasting administration. A single dose of AD16 tablets after fasting and high fat diet showed good safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
AD16 was administered with 240 mL water 30 minutes after the subjects ate a high-fat, high-calorie food.
Subjects took AD16 on an empty stomach and fasted within 4 hours after taking the drug.
The Central South University Xiang Ya Hospital
Changsha, China
Cmax of AD16
Maximum (peak) plasma drug concentration
Time frame: Up to Day 10
AUC 0-t of AD16
Area under the plasma concentration-time curve(AUC) from time zero to time t
Time frame: Up to Day 10
AUC 0-∞ of AD16
Area under the plasma concentration-time curve(AUC) from time zero to infinity
Time frame: Up to Day 10
t1/2 of AD16
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Time frame: Up to Day 10
Tmax of AD16
Time to reach the maximum (peak) plasma concentration following drug administration
Time frame: Up to Day 10
CL/F of AD16
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).
Time frame: Up to Day 10
Vd/F of AD16
Apparent volume of distribution after non-intravenous administration
Time frame: Up to Day 10
MRT of AD16
Mean residence time(MRT)
Time frame: Up to Day 10
λz of AD16
Terminal disposition rate constant/terminal rate constant
Time frame: Up to Day 10
Adverse events
The number of adverse events
Time frame: day-7 to day 10
Serious adverse events
The number of serious adverse events
Time frame: day-7 to day 10
Number of participants with abnormal laboratory test results
Laboratory tests include blood routine, blood biochemistry, coagulation function and urine routine
Time frame: day-7 to day-1 and day10
Number of participants with abnormal vital signs
vital signs include Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.
Time frame: day-7 to day3 and day7 to day10
Number of participants with abnormal 12- Lead ECG readings
abnormal 12- Lead ECG
Time frame: day-7 to day-1 and days3 、10
Number of participants with abnormal physical examination findings
The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication.
Time frame: day-7 to day-1 and day10
Concomitant medication
Any concomitant medication
Time frame: Up to Day 10
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