Table 3.
The Main PK Parameters of TPN171H Under Fasted and Fed Conditions After a Single Oral Dose of 10 Mg TPN171H
| Pharmacokinetic Parameters | Fasted (N=12) | Fed with Standard Meal (N =12) | Fed with High-Fat, High-Calorie Meal (N =12) |
|---|---|---|---|
| AUC0-t (h·ng/mL)* | 635.62 (84.93) | 622.00 (84.90) | 662.03 (59.03) |
| AUC0-∞ (h·ng/mL)* | 648.87 (85.24) | 638.43 (85.55) | 678.58 (63.24) |
| Cmax (ng/mL)* | 74.44 (13.50) | 57.67 (12.42) | 69.42 (21.29) |
| Tmax (h)* | 1.50 (0.50,2.00) | 4.00 (0.75,4.00) | 2.00 (0.33,6.00) |
| t1/2 (h) | 9.04 (0.72) | 9.30 (1.17) | 9.15 (0.96) |
| Vd/F (L) | 205.45 (40.36) | 215.42 (51.996) | 195.72 (25.31) |
| CL/F (L/h)* | 15.66 (2.11) | 15.9 (2.25) | 14.86 (1.42) |
Notes: Data are expressed as mean (SD), except for Tmax, which is shown as median (min, max). *P<0.05: The difference of the PK parameter under fasted and fed conditions is considered to be statistically significant.
Abbreviations: AUC0-t, area under the concentration–time curve from time zero to the time of the last measurable concentration; AUC0-∞, area under the concentration–time curve from time zero to infinity; Cmax, maximum observed plasma concentration; Tmax, time to maximum plasma concentration; t1/2, terminal elimination half-life; Vd/F, apparent distribution volume; CL/F, clearance rate.