Table 2.
Plasma PK variables for DR-HC in healthy subjects in the PK population. All pharmacokinetic variables are uncorrected and presented as mean (s.d.), with the exception of Tmax, which is presented as median (range).
| Parameter | 5mga | 15mga | 20mga | 20mgb |
|---|---|---|---|---|
| Cmax (ng/mL) | 82.0 (18.2) | 148.8 (29.3) | 177.1 (25.5) | 178.0 (28.1) |
| AUC0−∞ (h×ng/mL) | 562.8 (141.0) | 991.6 (162.0) | 1180.8 (213.8) | 1162.1 (175.7) |
| AUC0−12h (h×ng/mL) | 371.8 (75.8) | 770.4 (209.0) | 947.7 (174.2) | 919.5 (169.7) |
| Tmax (h) | 0.5 (0.3−1.0) | 0.5 (0.3−24.0) | 0.5 (0.3−5.0) | 0.5 (0.3−5.0) |
| Terminal half-life (h) | 13.7 (8.0) | 8.3 (5.1) | 6.0 (2.9) | 6.7 (3.6) |
| % extrapolated AUC (%)c | 17.4 (10.8) | 7.5 (6.7) | 4.3 (2.6) | 5.7 (4.9) |
Test site; breference site; cpercentage of the AUC resulting from extrapolation after the last measurable concentration. AUC, area under the concentration−time curve; AUC0−∞, total area under the concentration−time curve; AUC0−12h, area under the concentration−time curve to the last sample taken at 12h after dosing; Cmax, maximal serum concentration; PK, pharmacokinetic.
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