TABLE 1.
Pharmacokinetic parameters of vutiglabridin after a single oral administration in low‐fat, high‐fat and fasted states.
| Parameter | Low‐fat (N = 12) | High‐fat (N = 12) | Fasted (N = 12) | GMR a (90% CI) Low‐fat/fasted | GMR b (90% CI) High‐fat/fasted |
|---|---|---|---|---|---|
| C max (μg/L) | 1880 ± 565 | 2700 ± 880 | 961 ± 539 | 2.1417 (1.7646–2.5994) | 3.0661 (2.5263–3.7213) |
| AUClast (h∙μg/L) | 17,700 ± 4400 | 24,700 ± 6750 | 8410 ± 2970 | 2.1514 (1.9165–2.4152) | 2.9991 (2.6716–3.3667) |
| AUC0–24 (h∙μg/L) | 9810 ± 2410 | 14,000 ± 3410 | 4470 ± 1880 | – | – |
| AUCinf (h∙μg/L) | 20,800 ± 5430 | 29,000 ± 9130 | 9760 ± 3280 | – | – |
| T max (h) | 3.0 [2.0–4.0] | 3.0 [2.0–4.0] | 1.5 [1.0–4.0] | – | – |
| t 1/2 (h) | 93.5 ± 28.2 | 93.5 ± 18.5 | 85.2 ± 13.8 | – | – |
| CL/F (L/h) | 24.5 ± 6.2 | 17.7 ± 4.0 | 53.8 ± 15.7 | – | – |
| V d/F (h) | 3320 ± 1450 | 2330 ± 524 | 6610 ± 2200 | – | – |
Note: Data are presented as mean ± standard deviation, except for T max, which is presented as median [minimum − maximum].
Abbreviations: AUC0‐24, area under the concentration‐time curve from 0 to 24 hours; AUCinf, AUC from 0 to infinity; AUClast, area under the concentration‐time curve from 0 to last measurable timepoint; CI, confidence interval; CL/F, total apparent clearance; C max, maximum plasma concentration; GMR, geometric mean ratio; t 1/2, half‐life; T max, time to reach C max; Vd, volume of distribution.
a
GMR of low‐fat meal to fasted state.
b
GMR of high‐fat meal to fasted state.