Table 5. Pharmacokinetic parameters of duloxetine and thioctic acid in the test and reference groups (n = 12).
| Variables | Test (n = 6) | Reference (n = 6) | Ratio (test/reference) | p-value | |
|---|---|---|---|---|---|
| Duloxetine | |||||
| Cmax (ng/mL) | 49.32 ± 27.14 | 67.54 ± 81.74 | 0.73 (−0.24–1.70) | 0.818 | |
| Tmax (hr) | 1.50 (0.50–2.50) | 2.00 (0.50–2.50) | - | 0.818 | |
| AUClast (ng·h/mL) | 115.12 ± 73.40 | 141.77 ± 160.95 | 0.81 (−0.25–1.87) | 0.818 | |
| CL/F (L/h) | 387.03 ± 204.27 | 555.30 ± 312.39 | - | 0.352 | |
| Thioctic acid | |||||
| Cmax (ng/mL) | 12,923.58 ± 17,212.81 | 8,863.67 ± 4,815.53 | 1.46 (−0.64–3.56) | 0.699 | |
| Tmax (hr) | 0.63 (0.50–1.00) | 0.50 (0.25–1.00) | - | 0.240 | |
| AUClast (ng·h/mL) | 5,141.16 ± 5,611.99 | 4,165.74 ± 1,434.53 | 1.23 (−0.18–2.65) | 0.485 | |
| CL/F (L/h) | 173.79 ± 108.12 | 125.62 ± 38.29 | - | 0.485 | |
Data are presented as the mean ± standard deviation except for Tmax as the median (min–max).
Test group, fixed-dose combination tablet of duloxetine and thioctic acid; reference group, co-administered duloxetine and thioctic acid as separate doses; Cmax, peak plasma concentration; Tmax, time to peak concentration; AUClast, area under the plasma concentration vs. time curve from time 0 to the last quantifiable time point; CL, clearance.