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. 2019 Aug 22;13:2941–2955. doi: 10.2147/DDDT.S205000

Table 2.

Summary of pharmacokinetic parameters for olanzapine and samidorphan in subjects with moderate hepatic impairment and healthy control subjects after a single oral dose of OLZ/SAM (5 mg olanzapine/10 mg samidorphan)

Parameter, arithmetic mean (SD) Olanzapine Samidorphan
Moderate hepatic impairment (N=10) Healthy control (N=10) Moderate hepatic impairment (N=10) Healthy control (N=10)
Cmax (ng/mL) 10.65 (4.21) 4.91 (1.51) 50.71 (13.6) 30.77 (8.5)
tmax (hr)a 1.5 (0.5–4.0) 7.0 (2.0–12.0) 0.5 (0.5–1.0) 1.0 (0.5–3.0)
t1/2 (hr) 53.3 (16.1) 51.9 (18.0) 11.9 (2.3) 9.0 (0.8)
AUClast (hr×ng/mL) 376 (71) 237 (129) 397 (84) 256 (64)
AUC0-∞ (hr×ng/mL) 424 (84) 275 (149) 408 (87) 263 (65)
CL/F (L/hr) 12.2 (2.4) 22.2 (9.0) 25.5 (5.1) 39.8 (8.2)
Vz/F (L) 920 (249) 1555 (564) 429 (86) 514 (105)

Note: aMedian (min, max) presented for tmax.

Abbreviations: AUClast, area under the plasma concentration-time curve from time 0 to last observed concentration above the lower limit of quantification; AUC0-∞, area under the plasma concentration-time curve from time 0 to infinity; CL/F, apparent clearance; Cmax, maximum observed concentration; OLZ/SAM, olanzapine/samidorphan; SD, standard deviation; tmax, time to maximum observed concentration; t½, terminal elimination half-life; Vz/F, apparent volume of distribution.