Table 4.
Mean summary statistics of plasma vaniprevir pharmacokinetic parameters following administration of single oral doses (1,000 and 1,300 mg) in healthy male subjects
| Panel | Dose (mg) | AUC0–12h a (nM/h) | AUC0–∞ a (nM/h) | Cmax a (nM) | C12h a (nM) | C24h a (nM) | tmax b (h) | Apparent terminal t½ a (h) |
|---|---|---|---|---|---|---|---|---|
| D (period 1) | 1,000 | 12,517.93 (83.47) | 13,000.38 (83.05) | 3,865.39 (76.10) | 110.88 (105.65) | 8.85 (63.05) | 3.50 (3.00–4.00) | 3.1 (11.4) |
| E (period 1) | 1,000 | 16,505.14 (87.46) | 17,075.08 (86.01) | 5,903.18 (77.72) | 128.02 (57.51) | 10.48 (72.70) | 3.00 (2.00–4.02) | 3.3 (7.5) |
| D, E pooled | 1,000 | 14,373.94 (82.53) | 14,899.08 (81.61) | 4,776.83 (77.60) | 119.14 (78.10) | 9.63 (65.04) | 3.00 (2.00–4.02) | 3.2 (9.6) |
| E (period 2) | 1,300 | 32,250.61 (65.25) | 33,151.64 (65.05) | 9,198.88 (68.54) | 227.87 (67.46) | 16.38 (68.56) | 3.50 (3.00–6.00) | 2.9 (13.2) |
| E (period 3) | 1,300 | 24,146.87 (83.47) | 24,953.89 (82.85) | 7,578.83 (83.71) | 192.89 (79.74) | 12.52 (82.25) | 3.00 (3.00–6.00) | 3.0 (10.4) |
| E (periods 2 and 3) pooledc | 1,300 | 28,725.47 (69.66) | 29,590.91 (69.26) | 8,512.98 (70.23) | 213.17 (67.97) | 14.71 (70.72) | 3.00 (3.00–6.00) | 2.9 (11.7) |
AUC, area under the curve; C12h, plasma concentration at 12 h postdose; C24h, plasma concentration at 24 h postdose; Cmax, maximum concentration; tmax, time taken to reach Cmax occurred; t½, elimination half‐life.
a
Geometric mean and geometric coefficient of variation. bMedian (range). cData for repeat assessments to panel E (treatments E2 and E3) were pooled for overall pharmacokinetic summary following the 1,300‐mg (E2, E3) doses, respectively.