Table 5.

Pharmacokinetic Parameters of OP in Monkeys After IV Injection of OP and Oral Administration of OP-S or ODSF

Test Material	OP-IV	OP-S	ODSF
Administration route	IV	Oral	Oral
Dose of OP (mg/kg)	2	10	10
Tmax (h)	-	2.00±0.00	3.00±1.00
T1/2 (h)	45.9±5.46	49.4±5.45	37.4±5.59
Cmax (μg/mL)	0.691±0.099	0.043±0.006	0.192±0.038*
AUClast (μg·h/mL)	9.17±1.96	1.05±0.182	3.97±0.659*
AUCinf (μg·h/mL)	17.8±3.52	2.07±0.219	6.44±0.869**
MRT (h)	19.6±0.254	19.7±0.124	18.4±0.049**
Bioavailability (%)	100	2.29±0.398	8.64±1.44**

Notes: Statistics: Student’s t-test. Each value is mean±standard deviation (n=3). *P<0.05, **P<0.01, compared to OP-S. Bioavailability (%): (AUC_{last, oral}/Dose_{OP, oral})/(AUC_{last, IV}/Dose_{OP, IV})×100.

Abbreviations: OP, oxaliplatin; IV, intravenous; OP-S, OP in aqueous solution; DLM, N^α-deoxycholyl-l-lysyl-methylester; OP/DLM, ion-pairing complex between OP and DLM; P188, poloxamer 188; ODSF, solid oral formulation of OP/DLM with P188 and Labrasol; T_max, time to reach maximum plasma concentration; T_1/2, half-life of plasma concentration; C_max, maximum plasma concentration; AUC_last, area under the plasma concentration–time curve from zero to the time of the last measurable plasma concentration; AUC_inf, area under the plasma concentration–time curve from zero to infinity; MRT, mean residence time.