Table 2.
Summary of plasma pregabalin pharmacokinetic parameter values after oral administration of GLA5PR GLARS-NF1 150, 300, 450, and 600 mg
| Variable | Treatment groups
|
P-valuea | |||
|---|---|---|---|---|---|
| 150 mg (n=10) | 300 mg (n=10) | 450 mg (n=9) | 600 mg (n=9) | ||
|
|
|
|
|
|
|
| AUClast (h⋅ng−1⋅mL−1) | 26,439.53±5,606.82 | 52,995.99±5,916.89 | 77,632.88±12,525.10 | 106,053.94±17,346.78 | ⩽0.001 |
| AUClast/dose (h⋅ng−1⋅mL−1⋅mg−1) | 176.26±37.38 | 176.65±19.72 | 172.52±27.83 | 176.76±28.91 | 0.9874 |
| AUCinf (h⋅ng−1⋅mL−1) | 27,658.58±5,798.22 | 54,928.06±5,986.83 | 80,448.20±14,894.16 | 109,729.69±18,694.32 | ⩽0.001 |
| Cmax (ng/mL) | 2,063.04±436.24 | 3,975.90±539.13 | 5,799.61±1,213.89 | 7,342.02±1,374.87 | ⩽0.001 |
| Cmax/dose (ng⋅mL−1⋅dose−1) | 13.75±2.91 | 13.25±1.80 | 12.89±2.70 | 12.24±2.29 | 0.5962 |
| Tmax (h) | 6.00 [4.00–8.00] | 8.00 [5.00–12.0] | 6.00 [4.00–12.0] | 8.00 [4.00–10.0] | NA |
| t1/2 (h) | 6.51±0.89 | 6.37±0.33 | 6.23±0.85 | 6.23±0.69 | 0.804 |
| CL/F (L/h) | 5.69±1.44 | 5.52±0.59 | 5.75±1.00 | 5.62±1.03 | 0.968 |
| Vd/F (L) | 52.24±9.29 | 50.74±5.98 | 50.98±6.52 | 50.10±8.21 | 0.940 |
Notes: Data are means ± standard deviation, except for Tmax values, which are medians [min–max].
a
ANOVA was used.
Abbreviations: AUClast, area under the serum concentration-time curve from time zero to the time of the last measured concentration; Cmax, maximum serum concentration; Tmax, time to peak concentration; t1/2, half-life; CL/F, apparent clearance; Vd/F, apparent volume of distribution; NA, not applicable.