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. 2024 Jul 9;16(7):915. doi: 10.3390/pharmaceutics16070915

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