Table 4.
Exposure of JBD0131 and DM131 in Plasma of Beagle Dogs Following Oral Gavage Administration of JBD0131
| Analyte | Dosing days | Sex | Dose (mg/kg) | n | AUC0–24 (h*ng/mL) | AUC0–96 (h*ng/mL) | ||
|---|---|---|---|---|---|---|---|---|
| Mean | SD | Mean | SD | |||||
| JBD0131 | 1 | Female | 15 | 5 | 5020 | 1600 | / | / |
| 60 | 5 | 10,700 | 2800 | / | / | |||
| 300 | 5 | 12,900 | 4950 | / | / | |||
| Male | 15 | 4* | 5570 | 1900 | / | / | ||
| 60 | 5 | 13,900 | 4120 | / | / | |||
| 300 | 5 | 20,000 | 4270 | / | / | |||
| 28 | Female | 15 | 5 | 7340 | 2510 | 8530 | 3690 | |
| 60 | 4# | 15,700 | 3840 | 24,800 | 9280 | |||
| 300 | 5 | 19,400 | 5270 | 30,300 | 7150 | |||
| Male | 15 | 5 | 6530 | 1930 | 7180 | 2820 | ||
| 60 | 5 | 14,900 | 1520 | 20,100 | 3350 | |||
| 300 | 5 | 22,200 | 4870 | 32,300 | 8390 | |||
| DM131 | 1 | Female | 15 | 5 | 581 | 190 | / | / |
| 60 | 5 | 550 | 107 | / | / | |||
| 300 | 5 | 767 | 248 | / | / | |||
| Male | 15 | 4* | 630 | 192 | / | / | ||
| 60 | 5 | 721 | 148 | / | / | |||
| 300 | 5 | 1610 | 464 | / | / | |||
| 28 | Female | 15 | 5 | 1190 | 363 | 1640 | 559 | |
| 60 | 4# | 1720 | 656 | 3470 | 1680 | |||
| 300 | 5 | 1850 | 489 | 3630 | 975 | |||
| Male | 15 | 5 | 1090 | 363 | 1430 | 486 | ||
| 60 | 5 | 1780 | 381 | 3100 | 977 | |||
| 300 | 5 | 2270 | 694 | 4560 | 1620 | |||
*Following the first dose, the plasma concentration of Dog No. 3M002 in the 15 mg/kg group was significantly lower than that of other animals in the same group; therefore, its TK parameters were excluded from the statistical analysis
#Following the final dose, Dog No. 4F003 in the 60 mg/kg group vomited within 20 min after administration; therefore, its TK parameters were excluded from the statistical analysis