Table 2.
Pharmacokinetic Parameter | Total (n= 176) |
Men (n = 91) |
Women (n = 85) |
p-Value | African American (n = 2) |
European (n = 85) |
Latino (n = 89) |
p-Value |
---|---|---|---|---|---|---|---|---|
AUC (ng·h/mL) | 13,200.6 (2895.7) | 12,945.7 (2754.2) | 13,473.4 (3032.5) | 0.26 | 14,476.9 (3384.9) | 13,255.6 (2373.4) | 13,268.4 (3041.1) | 0.77 |
AUC/dW (ng·h·kg/mL·mg) | 966.4 (240.4) | 1042.5 (224.6) | 884.8 (231.1) | 0.18 | 1368.8 (309.3) | 999.4 (199.1) | 936.3 (245.9) | 0.01 |
Cmax (ng/mL) | 1509.6 (344.1) | 1464.2 (357.4) | 1558.2 (324.4) | 0.05 | 1580.6 (46.1) | 1473.3 (324.1) | 1542.6 (364.4) | 0.40 |
Cmax/dW (ng·kg/mL·mg) | 110.3 (27.5) | 117.8 (27.6) | 102.3 (25.2) | <0.01 | 149.6 (3.2) | 111.1 (26.4) | 108.7 (28.3) | 0.14 |
Tmax (h) | 4.3 (1.3) | 4.5 (1.4) | 4.1 (1.2) | 0.02 | 5.5 (2.1) | 4.4 (1.0) | 4.2 (1.5) | 0.17 |
T1/2 (h) | 4.2 (0.7) | 4.0 (0.6) | 4.5 (0.6) | <0.01 | 3.8 (0.3) | 4.2 (0.6) | 4.3 (0.6) | 0.30 |
Vd/F (mL/kg) | 6335.5 (2951.6) | 5236.0 (2191.0) | 7499.7 (3208.3) | 0.99 | 4067.6 (563.8) | 5941.2 (2523.9) | 6767.9 (3287.9) | 0.85 |
Cl/F (mL/h·kg) | 1009.4 (389.4) | 886.8 (327.7) | 1139.2 (409.0) | 0.39 | 749.7 (169.4) | 986.9 (334.5) | 1054.4 (435.6) | 0.70 |
Values are shown as mean (SD). Abbreviation: AUC, area under the curve; Cmax, maximum plasma concentration; Tmax, time to reach the maximum plasma concentration; T1/2, half-life; Cl/F, total drug clearance adjusted for bioavailability; Vd/F, volume of distribution adjusted for bioavailability; dW, adjusted for dose and weight ratio.