TABLE 5

Plasma PK parameters in oral TBPM-PI-HBr given q8h for 14 days in the MAD phase (PK analysis population)

DayTBPM-PI-HBr
dose
Median
(range) for
Tmax (h)
Arithmetic mean (% CV)
Cmax
(ng/ml)
AUC0–8
(h·ng/ml)
t1/2
(h)
Nominal dose
CL (liters/h)V (liters)
1300 mg (n = 6)0.5 (0.25–1.0)7,759 (50.7)7,726 (27.2)0.82 (26.9)32.4 (35.6)37.0 (28.2)
600 mg (n = 6)0.88 (0.5–1.5)13,428 (31.9)20,592 (19.3)0.79 (12.1)23.2 (19.5)26.2 (19.2)
14300 mg (n = 6)0.63 (0.47–1.5)6,493 (61.5)7,484 (36.5)0.72 16.0)34.8 (39.3)36.5 (47.8)
600 mg (n = 6)0.63 (0.5–1.5)15,090 (30.8)17,924 (25.4)0.83 (20.0)27.5 (30.1)31.8 (21.4)