Pharmacokinetics
PK analyses were performed based on plasma zuranolone concentration data after single‐ and 7‐day multiple‐dose administration of zuranolone in Part A and single‐dose administration in Parts B and C. The mean plasma concentration profile of zuranolone after single‐dose administration in Parts A and B is shown in Figure Plasma concentration profiles of a single dose of zuranolone in (A) Japanese healthy adults, (B) White healthy adults, (C) Japanese healthy elderly, and (D) Japanese healthy adults in fasted and fed states (PK concentration population). h, hour; mg, milligram; mL, milliliter; ng, nanogram; PK, pharmacokinetics; SD, standard deviation.Summary of PK parameters after a single‐dose administration of zuranolone (PK parameter population).Abbreviations: AUCMedian (min, max).
After multiple‐dose administration of zuranolone, plasma concentrations reached a steady state within 72 h in Japanese and White adults and within 7 days in Japanese elderly (Figure Plasma concentration profiles of multiple doses of zuranolone in (A) Japanese healthy adults, (B) White healthy adults, and (C) Japanese healthy elderly (PK concentration population). h, hour; mg, milligram; mL, milliliter; ng, nanogram; PK, pharmacokinetics; SD, standard deviation.Statistical analysis of dose proportionality of In Part B, plasma exposures of zuranolone were greater in the fed than in the fasted state (Figure The median 