Table 1.
Mean (SD) Serum Pharmacokinetic Parameters of All the Volunteers for the Test and Reference Formulations.
| Pharmacokinetic Parameters | Test (n = 14) | Reference (n = 14) | P Value |
|---|---|---|---|
| Cmax, ng/mL | 683.00 (94.54) | 635.16 (125.57) | .2636 |
| Tmax, h | 2.27 (0.07) | 2.21 (0.09) | .0597 |
| AUC0-12, ng·h/mL | 2716.54 (196.28) | 2780.50 (119.73) | .3075 |
| AUC0-∞, ng·h/mL | 3284.36 (138.12) | 3317.96 (133.95) | .4977 |
| Kel, h−1 | 3.62 (0.39) | 3.32 (0.43) | .0641 |
| AUMC0-12, ng·h2/mL | 10 164.79 (466.03) | 10 368.89 (512.72) | .2805 |
| AUMC0-∞, ng·h2/mL | 16 868.61 (859.80) | 16 786.76 (831.91) | .8000 |
| t1/2, h | 3.30 (0.23) | 3.16 (0.14) | .0626 |
| MRT, h | 5.49 (0.21) | 5.36 (0.14) | .0649 |
Abbreviations: MRT, mean residence time; SD, standard deviation.