Table 5. Summary of the midazolam PK in Chinese after oral administration.
| PK parameter | Current study Age 20–45 years (n=10) | Study 1 Age 23±2.3 years (n=10) | Study 2 Age 20–28 years (n=22) | Study 3 Age 22–32 years (n=42) |
|---|---|---|---|---|
| Dose 15 mg | Dose 15 mg | Dose 7.5 mg | Dose 7.5 mg | |
| Cmax (ng/mL) | 73.5±27.3 | 103.1±26,4 | 53.4±22.1 (POR*28, CC) | 30–40 |
| 57.6±14.6 (POR*28, CT) | ||||
| 60.7±19.3 (POR*28, TT) | ||||
| Tmax (median) | 0.5 (0.25-1.5) | 1.5±0.7 | 0.5±0.2 (POR*28, CC) | 0.5–2 |
| 0.4±0.1 (POR*28, CT) | ||||
| 0.4±0.1 (POR*28, TT) | ||||
| T1/2 (h) | 3.3±0.9 | 3.0±0.8 | 2.3±0.8 (POR*28, CC) | NA |
| 2.0±0.4 (POR*28, CT) | ||||
| 2.1±0.4 (POR*28, TT) | ||||
| AUC0-t (h·ng/mL) | 198.7±51.1 | 369.8±103.6 | 95.7±34.4 (POR*28, CC) | 154.0±17.5 (CYP3A5*3) |
| 88.6±20.5 (POR*28, CT) | 132.2±12.8 (CYP3A5*1*3) | |||
| 94.6±14.0 (POR*28, TT) | ||||
| AUC0-∞(h·ng/mL) | 211.6±52.6 | 397.3±124.1 | 104.8±39.6 (POR*28, CC) | NA |
| 93.7±23.4 (POR*28, CT) | ||||
| 100.1±14.6 (POR*28, TT) | ||||
| CL/F (L/h) | 75.3±20.5 | 41.2±13.1 | 80.1±27.1 (POR*28, CC) | NA |
| 84.3±19.7 (POR*28, CT) | ||||
| 76.2±10.1 (POR*28, TT) | ||||
| Reference | 26 | 25 | 27 |
NA: not available.