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. 2019 Feb 11;14(1):67–74. doi: 10.1007/s11523-018-00618-0

Table 2.

Pharmacokinetic parameters for a 200 mg tablet of BI 853520 administered under fed and fasted conditions

Parameter Fed Fasted Adjusted GMR,  % (90% CI) [fed/fasted]
Patients, n 15 15
t max a 4 [1–24] 3 [1–6]
AUC0-tz, nM·h 30,992c 33,518 92.46 (74.24–115.16)
AUC0–∞,obs, nM·h 39,219 39,949 98.17 (78.53–122.74)
Cmax, nM 1636 1873 87.34 (71.04–107.38)
t½, hb 18.0 (16.1)c 18.0 (22.6)

Unless otherwise specified, data are adjusted geometric mean

AUC0∞,obs observed area under the plasma concentration–time curve extrapolated from time zero to infinity, AUC0-tz area under the plasma concentration–time curve from time zero to the last quantifiable concentration at tz, Cmax maximum plasma concentration, t½ terminal half-life, tmax time to maximum plasma concentration, – not calculated

aMedian [range]

bGeometric mean [coefficient of variation (%)]

cn = 14