Table 6.
Predicted pharmacokinetic parameters following single-dose administration of the tested 20 mg PRH buccal films and 20 mg and 40 mg IR tablets in 50 virtual subjects.
| Formulation (Dose) | Cmax (ng/mL) | tmax (h) | AUC0–∞ (ng h/mL) | F (%) | ||||
|---|---|---|---|---|---|---|---|---|
| Mean (Range) | CV% | Mean (Range) | CV% | Mean (Range) | CV% | Mean (Range) | CV% | |
| F2 (20 mg) |
42.13 (23.16–71.36) |
26.59 | 3.10 (1.86–4.58) |
19.43 | 404.87 (197.69–803.03) |
34.80 | 99.89 (99.88–99.90) |
2.62 × 10−3 |
| F4 (20 mg) |
40.72 (21.43–68.54) |
24.26 | 4.78 (3.24–7.08) |
16.98 | 451.74 (210.46–808.55) |
31.49 | 99.99 (99.93–100.00) |
1.08 × 10−2 |
| F6 (20 mg) |
41.67 (23.08–70.61) |
26.56 | 3.70 (2.56–5.16) |
15.32 | 404.10 (197.32–801.51) |
34.80 | 99.70 (99.69–99.71) |
2.77 × 10−3 |
| IR tablet (20 mg) |
22.81 (0.74–54.38) |
45.42 | 1.12 (0.65–1.62) |
19.35 | 168.02 (4.44–461.53) |
53.45 | 35.24 (1.00–54.92) |
33.82 |
| IR tablet (40 mg) |
48.14 (1.23–100.97) |
44.76 | 1.08 (0.74–1.62) |
16.99 | 319.63 (5.36–1088.80) |
57.97 | 33.12 (1.32–57.57) |
36.38 |
Cmax—maximum plasma concentration; tmax—time to reach Cmax; AUC—area under the plasma concentration-time curve; F—bioavailability, CV%—coefficient of variation.