Table 2 Primary PK evaluation (PK analysis set)
Parameter (units) | Sulfamethoxazole | Trimethoprim | ||
|---|---|---|---|---|
mean ± SD (% CV) | mean ± SD (% CV) | |||
Test (N = 25) | Reference (N = 25) | Test (N = 26) | Reference (N = 25) | |
Tmax (h)* | 2.5 (0.75,4.00) | 1.5 (0.75,5.00) | 0.75 (0.33,2.00) | 1.00 (0.33,3.50) |
Cmax (ng/mL) | 29,500 ± 5800 (19.7) | 27,100 ± 5620 (20.7) | 894 ± 208(23.2) | 863 ± 163 (18.9) |
AUC0 − t (ng·h/mL) | 330511.74 ± 44951.68 (13.6) | 323200.10 ± 38368.41 (11.87) | 8362.34 ± 1999.94 (23.92) | 8120.30 ± 2042.16 (25.15) |
AUC0−∞ (ng·h/mL) | 339444.27 ± 47932.52 (14.12) | 331787.30 ± 40534.69 (12.22) | 8536.13 ± 2059.01 (24.12) | 8286.28 ± 2095.23 (25.29) |
λz (1/h) | 0.08 ± 0.01 (13.11) | 0.08 ± 0.01 (13.35) | 0.10 ± 0.01 (14.67) | 0.10 ± 0.02 (15.76) |
T1/2z (h) | 8.74 ± 1.15 (13.11) | 8.80 ± 1.12 (12.76) | 7.17 ± 1.11 (15.49) | 7.18 ± 1.18 (16.47) |