GMP-grade α-TEA lysine salt: a 28-Day oral toxicity and toxicokinetic study with a 28-Day recovery period in Beagle dogs

Table 9 Mean toxicokinetic parameters at day 1 and 28-day dosing of α-TEA lysine salt

Day	Group	α-TEA Dose (mg/kg)	Sex	Tmax (hr)	T1/2 (hr)	Cmax (ng/mL)	AUC0-24 (hr*ng/ml)
1	2	100	Male	24	NC	20200	335000
1	2	100	Female	20	NC	23900	35100
1	3	300	Male	16	NC	41000	718000
1	3	300	Female	18.7	NC	48600	72900
1	4	1500	Male	24	NC	69100	1170000
1	4	1500	Female	16	NC	76900	1240000
28	2	100	Male	6.3	NC	148000	3290000
28	2	100	Female	7	NC	16000	3620000
28	3	300	Male	7.3	NC	211000	4740000
28	3	300	Female	8	NC	212000	4670000
29	4	1500	Male	8	NC	206000	4580000
28	4	1500	Female	10.7	NC	192000	4210000

Blood were collected collected at 1, 2, 4, 8, and 24 h following the first α-TEA administration and 2, 8, 24, 72, and 168 h following the last administration (day 28). The validated method (high performance liquid chromatography with mass spectrometric detection) was used to analyse plasma α-TEA concentration. C_max, T_max, T_1/2, AUC were determined using WinNonlin Version 6.2 software system

ISSN: 1471-2407