. 2023 Mar 8;41(2):296–305. doi: 10.1007/s10637-022-01325-4

Table 3.

Pharmacokinetic Parameters After a Single Oral Dose and Multiple Oral Doses of SYHA1813

Parameter	Dose
	5 mg		15 mg		30 mg
	Mean	SD	Mean	SD	Mean	SD
A single dose
No. of patients	1		8		5
C_max, ng/mL	48.5	/	148.9	32.1	301.4	55.6
C_max/dose, ng/mL/mg	9.7	/	9.9	2.1	10.0	1.9
^aT_max, h	2.0	2.0	2.0	0.5–2.1	2.0	2.0-2.1
t_1/2, h	36.8	/	26.5	6.6	30.9	6.2
AUC_inf, h·ng/mL	1149.9	/	3040.3	1172.0	7421.7	2788.1
AUC_inf/dose, h·ng/mL/mg	230.0	/	202.7	78.1	247.4	92.9
V_z/F, L	231.0	/	199.7	45.2	188.8	35.4
CL/F, L/h	4.3	/	5.6	2.1	4.4	1.2
At steady state
No. of patients	1		5		3
C_{min, ss}, ng/mL	48.5	/	94.3	55.1	206.0	31.0
C_{max, ss}, ng/mL	127.0	/	248.0	88.9	376.0	80.6
C_{max, ss}/dose, ng/mL/mg	25.4	/	16.5	5.9	12.5	2.7
^aT_{max, ss}, h	1.0	1.0	2.0	0.9-2.0	8.0	2.0–8.0
t_1/2, h	35.7	/	27.6	6.9	32.9	1.5
AUC_ss, h·ng/mL	1487.5	/	3354.1	1651.2	6599.5	783.5
AUC_inf/dose, h·ng/mL/mg	791.5	/	511.9	395.2	557.2	55.6
V_ss, L	173.1	/	196.9	59.2	218.0	26.2
CL_ss/F, L/h	3.4	/	5.3	2.3	4.6	0.5
R_ac (C_max)	2.6	/	1.7	0.3	1.1	0.0
R_ac (AUC)	3.3	/	2.3	0.5	1.8	0.3

Abbreviations: SD, standard deviation; C_max, maximum plasma drug concentration after single-dose administration; C_min, _ss, minimum steady-state drug concentration in plasma; T_max, time to maximum concentration; t_1/2, terminal elimination half-life; AUC_inf, area under plasma concentration-time curve from zero to infinity; AUC_ss, area under plasma concentration-time curve at steady-state; V_z/F, volume of distribution; V_ss, volume of distribution at steady-state; CL/F, apparent oral clearance; CL_ss/F, apparent oral clearance at steady-state; R_ac, accumulation ratio index.

^aT_max (h) is presented as the median and range.