Table 6.

Comparison of Exposure Between Rats¹ and Humans

Rat Dose	Human Dose	Exposure Multiple (Rat Dose/Human Dose)2
mg/kg(mg/m2)3	mg/kg(mg/m2)4	mg/kg	mg/m2	Cmax		AUC
				Ref 15	Ref 2	Ref 1	Ref 2
5 (30)	0.143 (5.4)	35	5.5	5.3	13.6	4.1	8.5
20 (120)	-	140	120	14.7	37.6	13.4	27.9

¹Data used was from the current study. In dams for 5mg/kg and for 20 mg/kg, respectively, C_max (ng/mL) was 342 and 948 and AUC (ng.h/mL) was 2120 and 6960 (Table 2)

²Exposure multiples given are the ratio of rat dose/human dose estimated using mg/kg, mg/m², C_max and AUC

³mg/m² values were estimated using K_m value of 6kg/m2 for rats (Reagen-Shaw et al., 2008)

⁴Human doses mg/kg and mg/m² were calculated assuming 10mg dose taken by a 70kg person (0.143mg/kg) and using a K_m value of 37kg/m² for humans (Reagen-Shaw et al., 2008)

⁵Two human studies were used for comparison. The following C_max (ng/mL) and AUC (ng.h/mL) values, respectively, reported following use of 10mg of vinpocetine product were used: 64.3 and 519.7 (Ref 1, Elbary et al., (2002); 25.2 and 249.43 (Ref 2, Kharshoum (2013))