The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic characteristics of single administration of AD16 tablets in healthy adults under fasting conditions, and the secondary objective was to preliminarily evaluate the material balance of single administration of AD16 tablets in fasting conditions. The study is divided into two parts: preliminary test and formal test. The formal trial was a single-center, randomized, placebo-controlled, double-blind, dose-increasing study, with 5 dose groups (5mg, 10mg, 20mg, 30mg and 40mg, respectively). Ten subjects (male and female) were enrolled in each dose group, of which 8 received the experimental drug and 2 received placebo. Urine and fecal samples were collected in the 20mg dose group for material balance study.Urine and fecal samples were collected in the 20mg dose group for material balance study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Take one AD16 tablet in the morning
Participants will take a placebo pill matching AD16 once in the morning
The Central South University Xiang Ya Hospital
Changsha, China
Adverse events
The number of adverse events
Time frame: day-7 to day3
Serious adverse events
The number of serious adverse events
Time frame: day-7 to day3
Number of participants with abnormal laboratory test results
Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine
Time frame: Screening period (day-7 to day-2) and day3
Number of participants with abnormal vital signs
Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.
Time frame: day-7 to day3
Number of participants with abnormal 12-lead electrocardiogram readings
abnormal 12-lead electrocardiogram readings
Time frame: Screening period (day-7 to day-2) and day3
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: Screening period (day-7 to day-2) and day3
Concomitant Medication
Any concomitant medication
Time frame: up to day3
Tmax of AD16
Time to reach the maximum (peak) plasma concentration following drug administration
Time frame: day1 to day3
Cmax of AD16
Maximum (peak) plasma drug concentration
Time frame: day1 to day3
t1/2z of AD16
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Time frame: day1 to day3
AUC 0-∞ of AD16
AUC 0-∞ is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time). area under curve(AUC)
Time frame: day1 to day3
AUC 0-t of AD16
AUC 0-t is defined as the concentration of drug from time zero to the last quantifiable concentration.area under curve(AUC)
Time frame: day1 to day3
CL/F of AD16
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F). administration
Time frame: day1 to day3
Vd/F of AD16
Apparent volume of distribution after non-intravenous administration
Time frame: day1 to day3
λz of AD16
Terminal disposition rate constant/terminal rate constant
Time frame: day1 to day3
Mean retention time(MRT )of AD16
Mean retention time from first dosing to t hours or mean retention time from first dosing to infinity
Time frame: day1 to day3
Ae
The amount of drug excreted in urine at t hours after administration The amount of drug excreted by fecal sample at t hours after administration
Time frame: day-3 to day3
Fe0-t
Cumulative excretion rate of drugs through urine Cumulative rate of drug excretion through feces
Time frame: day-3 to day3
Renal clearance
Renal clearance of drug from plasma
Time frame: day-3 to day3
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