Table 1.
PK parameters for β-lapachone after single 100 mg and multiple 100 mg twice daily oral administration of MB12066 in healthy Korean male subjects (n=8)
| PK parameter | Single dose (day 1) | Multiple dose (8 days) |
|---|---|---|
| tmax (h)a | 3 (2–5) | 5 (1–5) |
| Cmax (ng/mL) | 3.56±1.55 | 14.96±15.56 |
| Cmin (μg/mL) | N/A | 1.73±0.65 |
| Cav (μg/mL) | N/A | 4.20±2.47 |
| t½ (h) | 5.89±3.41 | 18.16±3.14 |
| AUC0–t (ng·h/mL) | N/A | 85.97±32.59 |
| AUC0–τ (ng·h/mL) | 16.16±4.93 | 50.44±29.68 |
| AUC0–∞ (ng·h/mL) | 22.71±7.64 | 93.69±31.59 |
| Fluctuation (%) | N/A | 242.37±164.80 |
| Accumulation index | N/A | 2.72±0.37 |
Notes: Values are reported as arithmetic mean ± SD unless otherwise specified.
a
Median (range).
Abbreviations: PK, pharmacokinetic; N/A, not applicable; SD, standard deviation; tmax, time to reach Cmax; Cmax, maximum plasma concentration; Cmin, minimum steady-state concentration; Cav, average concentration; t½, elimination half-life; AUC0–t, area under the plasma concentration vs time curve from 0 to the last quantifiable time point; AUC0–τ, area under the plasma concentration vs time curve at steady state; AUC0–∞, area under the plasma concentration vs time curve from 0 to infinity.