Table 3.
Parameters | Marketed Product | F4 | F8 |
---|---|---|---|
AUC0–7day (ng·h/mL) | 2787.4 ± 187.4 | 1500.4 ± 218.9 * | 1022.2 ± 161.9 *,** |
Cmax (ng/mL) | 218.7 ± 26.6 | 75.6 ± 17.2 * | 32.2 ± 12.0 *,** |
Tmax (h) | 3.7 ± 0.8 | 1.8 ± 0.4 * | 1.4 ± 0.5 * |
T1/2 (h) 1 | 5.3 ± 0.1 | 9.0 ± 0.5 * | 13.3 ± 2.7 *,** |
1 Calculated from the plasma concentration–time curve from Tmax to 24 h after IA injection; Notes: Data are expressed as mean ± SD (n = 5). Statistical analysis was performed using the one-way ANOVA test; * significantly different from the marketed product (p < 0.05), ** significantly different from F4 (p < 0.05); Abbreviations: AUC0–7days, area under the plasma concentration–time curve until day 7; Cmax, maximum plasma concentration; Tmax, time to reach maximum plasma concentration; T1/2, elimination half-life of the drug.