Table 2. Pharmacokinetics of solifenacin after the administration of a single oral dose of the test formulation (solifenacin tartrate 10.66 mg) versus the reference formulation (solifenacin succinate 10 mg) in healthy male subjects.
| Parameter | Test (N=33) | Reference (N=33) | ||
|---|---|---|---|---|
| Mean±SD | Median (min–max) | Mean±SD | Median (min–max) | |
| AUClast (h·ng/mL) | 487.0 ± 138.5 | 438.8 (245.6 – 963.4) | 469.1 ± 128.3 | 443.5 (258.1 – 880.8) |
| Cmax (ng/mL) | 14.7 ± 3.9 | 14.1 (7.7 – 27.0) | 14.1 ± 3.4 | 13.8 (7.8 – 23.3) |
| AUCinf (h·ng/mL) | 640.3 ± 213.9 | 595.0 (283.5 – 1324.6) | 609.1 ± 190.7 | 596.3 (307.6 – 1232.7) |
| Tmax (h) | 4.7 ± 0.9 | 5.0 (3.0 – 6.0) | 5.0 ± 0.8 | 5.0 (3.0 – 6.0) |
| t1/2 (h) | 33.4 ± 8.1 | 30.6 (23.9 – 55.7) | 32.4 ± 4.0 | 30.8 (25.5 – 51.0) |
| CL/F (L/h) | 12.9 ± 4.1 | 12.6 (5.7 – 26.5) | 13.4 ± 4.0 | 12.6 (6.1 – 24.4) |
| Vd/F (L) | 595.9 ± 156.2 | 568.9 (309.0 – 1076.7) | 608.7 ± 152.4 | 605.4 (345.9 – 1081.0) |
Notes: Test=solifenacin tartrate 10.66 mg; Reference=solifenacin succinate 10 mg
Values are presented as the mean ± standard deviation; AUClast, area under the plasma concentration-time curve to the last sampling time; Cmax, maximum plasma concentration; AUCinf, area under the plasma concentration time-curve to infinity; Tmax, time to Cmax; t1/2, elimination half-life; CL/F, apparent clearance; Vd/F, apparent volume of distribution.