Table 2.
Summary of LCB01-0371 pharmacokinetic parameters after a single 800 mg dose of LCB01-0371 under fed and fasting conditions
| Pharmacokinetic parameter | LCB01-0371 800 mg
|
GMRb (90% CI) | |||
|---|---|---|---|---|---|
| Fed (N=17)
|
Fasted (N=17)
|
||||
| Mean ± SDa | CV (%) | Mean ± SDa | CV (%) | ||
| Tmax (h) | 2.00 (1.00–6.00) | 0.75 (0.50–3.00) | – | ||
| Cmax (mg/L) | 7.26±2.58 | 35.6 | 11.74±5.38 | 45.9 | 0.666 (0.470–0.945) |
| AUClast (mg h/L) | 18.25±4.51 | 24.7 | 20.46±5.23 | 25.6 | 0.897 (0.761–1.057) |
| AUCinf (mg h/L) | 18.41±4.51 | 24.5 | 20.56±5.24 | 25.5 | 0.900 (0.765–1.060) |
| t1/2 (h) | 1.53±0.14 | 9.0 | 1.68±0.44 | 26.0 | – |
Notes: AUClast, AUC from time zero to the last observed time point; AUCinf, AUC from time zero to infinity; Cmax, maximum plasma concentration; t1/2, terminal elimination half-life; Tmax, time to reach maximum plasma concentration.
a
Data are presented as mean ± SD except for Tmax, for which median (minimum–maximum) is presented.
b
GMR of pharmacokinetic parameter under fed condition to fasting condition. “–” = not applicable.
Abbreviations: AUC, area under the plasma concentration–time curve; CV, coefficient of variation; GMR, geometric mean ratio.