Table 3.
Bioequivalence Analysis of Main Pharmacokinetic Parameters of Pramipexole After Administration of 0.375 Mg Test and Reference Drugs in Healthy Chinese Subjects Under Fasted and Fed States
| Parameters | Geometric Mean | Geometric Mean Ratio (%) | Intra-Individual CV (%) | Power (%) | ||
|---|---|---|---|---|---|---|
| Test | Reference | Test/Reference | 90% CIs | |||
| Under fasted state | N=27 | N=26 | ||||
| Cmax (pg/mL) | 394.55 | 401.50 | 98.27 | (90.47, 106.74) | 17.29 | 99.29 |
| AUC0-t (h*pg/mL) | 8602.02 | 8439.65 | 101.92 | (95.74, 108.51) | 13.03 | > 99.99 |
| AUC0-∞(h*pg/mL) | 9279.60 | 8845.17 | 104.91 | (98.24, 112.04) | 13.72 | 99.73 |
| Under fed state | N=28 | N=28 | ||||
| Cmax (pg/mL) | 509.38 | 518.13 | 98.31 | (92.62, 104.36) | 13.15 | > 99.99 |
| AUC0-t (h*pg/mL) | 8914.73 | 8830.97 | 100.95 | (97.23, 104.81) | 8.25 | > 99.99 |
| AUC0-∞(h*pg/mL) | 9241.95 | 9163.33 | 100.86 | (97.19, 104.67) | 8.15 | > 99.99 |
Notes: Cmax and AUC between the test and reference formulation were considered to be equivalent if the 90% CIs of geometric mean ratios of Cmax and AUC were located within 80%–125%.
Abbreviations: Cmax, peak concentration; AUC0-t, plasma area under concentration–time curve from time 0 to the last measurable concentration; AUC0-∞, plasma area under concentration–time curve from time 0 to infinity; CIs, confidence intervals; CV, variation rate.