Table 2. Descriptive summary of plasma ertugliflozin PK parameter values on day 6.
PK parameter summary statistics by treatment | ||||
---|---|---|---|---|
Total daily dose 5 mg | Total daily dose 15 mg | |||
Ertugliflozin 2.5 mg BID | Ertugliflozin 5 mg QD | Ertugliflozin 7.5 mg BID | Ertugliflozin 15 mg QD | |
N, n | 22, 20 | 22, 22 | 27, 26 | 28, 28 |
AUC24, ng×h/mL | 399.2 (18) | 397.9 (18) | 1,192 (20) | 1,193 (22) |
Cmax1, ng/mL | 47.5 (25)a | 81.3 (29) | 154.2 (20) | 268.2 (20) |
tmax1, h | 1.0 (0.5 – 1.1)a | 1.0 (0.5 – 2.1) | 1.0 (0.5 – 2.0) | 1.0 (0.5 – 2.1) |
Cmax2, ng/mL | 42.8 (28) | NA | 140.1 (21) | NA |
tmax2, h | 2.0 (1.0–2.1) | NA | 1.0 (1.0–2.0) | NA |
Values are geometric mean (geometric percent coefficient of variation) for AUC24 and Cmax; or median (range) for tmax. Cmax1 and tmax1 indicate post morning dosing for the BID regimen. Cmax2 and tmax2 indicate post evening dosing for the BID regimen. AUC24 = area under the plasma concentration-time curve over 24 hours; BID = twice daily; Cmax = maximum observed plasma concentration; N = number of subjects in the treatment group; n = number of subjects contributing to the summary statistics; NA = not assessed; PK = pharmacokinetics; QD = once daily; tmax = time to maximum plasma concentration. a21 subjects were included in summary statistics for Cmax1 and tmax1.