Table 3.
Comparative pharmacokinetic parameters of TDF and reference TD-TAB (Cialis®) in healthy human volunteers under fasting and fed states.
| Condition | Items | Variable | ||||
|---|---|---|---|---|---|---|
| Cmax (ng/mL) | T/R, 90% CI | AUCt (h*ng/mL) | T/R, 90% CI | Tmax (h) | ||
| Fasting (n = 37) | TD-TAB | 268.2 ± 77.7 | 0.936–1.105 | 6399.8 ± 2447.9 | 1.012–1.153 | 2.6 ± 1.7 | 
| TDF-1 | 276.3 ± 83.9 | 6871.8 ± 2234.5 | 3.2 ± 2.2 | |||
| Fed I (n = 10) | TD-TAB | 416.4 ± 81.0 | 0.610–0.798 | 6562.4 ± 1269.4 | 0.884–1.022 | 2.3 ± 1.0 | 
| TDF-1 | 290.4 ± 81.0 | 6237.3 ± 1548.0 | 7.9 ± 3.2 | |||
| Fed II (n = 12) | TD-TAB | 326.8 ± 77.4 | 0.735–0.972 | 6549.6 ± 3034.0 | 0.894–1.137 | 2.6 ± 2.6 | 
| TDF-2 | 276.2 ± 100.3 | 6602.3 ± 3028.6 | 5.7 ± 6.1 | |||
| Fed III (n = 10) | TD-TAB | 408.6 ± 153.6 | 0.635–0.847 | 7097.6 ± 2631.7 | 0.929–1.074 | 3.2 ± 1.5 | 
| TDF-1 | 299.6 ± 102.3 | 7089.9 ± 2525.1 | 6.8 ± 3.2 | |||
| Fed IV (n = 8) | TD-TAB | 400.8 ± 61.2 | 0.851–0.998 | 6354.9 ± 1542.9 | 0.958–1.045 | 2.4 ± 2.1 | 
| TDF-1 | 367.3 ± 59.2 | 6382.5 ± 1501.7 | 4.8 ± 1.7 | |||