Parameters Fasting condition (Mean±SD, %CV) Fasting condition (Mean±SD, %CV) Fed condition (Mean±SD, %CV) Fed condition (Mean±SD, %CV)
Test (N=40) Reference (N=39) Test (N=38) Reference (N=38)
Tmax (hour)* 5.00 (2-23.99) 5.00 (2-23.99) 4.03 (2-10)** 5.00 (2-8)
Cmax(ng/mL) 208.01±70.19(33.75) 209.60±68.16(32.52) 242.95±82.08(33.79)** 260.05±92.15(35.44)
AUC0-t (h*ng/mL) 6520.42±2830.07(43.40) 6609.04±2464.83(37.29) 6875.41±2930.75(42.63) 7090.32±2710.62(38.23)
AUC0-∞ (h*ng/mL) 6883.55±3274.47(47.57) 6903.16±2761.19(40.00) 7168.45±3350.06(46.73) 7334.52±2998.07(40.88)
t1/2 (hour) 35.10±14.31(40.78) 33.64±12.69(37.71) 31.53±14.32(45.41) 29.50±10.56(35.81)
Median (range), **C003 subject had only the first cycle Cmax and Tmax as valid PK parameters. * Median (range), **C003 subject had only the first cycle Cmax and Tmax as valid PK parameters. * Median (range), **C003 subject had only the first cycle Cmax and Tmax as valid PK parameters. * Median (range), **C003 subject had only the first cycle Cmax and Tmax as valid PK parameters. * Median (range), **C003 subject had only the first cycle Cmax and Tmax as valid PK parameters. * Median (range), **C003 subject had only the first cycle Cmax and Tmax as valid PK parameters.