Table 2.
PK parameters for steady-state AZD5363 in Parts A and B (PK analysis set)
Parameter | N | Part A | |||
---|---|---|---|---|---|
Tablet | Capsule | Ratio tablet:capsule | |||
Gmean (CV%) | Gmean (CV%) | GLSM ratio | 90% CI | ||
AUCτ, h ng/mL | 11 | 8536 (47.7) | 9445 (44.6) | 0.90 | 0.77, 1.06 |
Cmax, ng/mL | 11 | 1779 (46.2) | 1745 (40.2) | 1.02 | 0.86, 1.20 |
Cmin, ng/mL | 11 | 192.6 (55.6) | 271.5 (57.7) | NC | NC |
tmax, ha | 11 | 1.0 (0.6–2) | 2.0 (1–4) |
Parameter | N | Part B | |||
---|---|---|---|---|---|
Fasted | Fed | Ratio fed:fasted | |||
Gmean (CV%) | Gmean (CV%) | GLSM ratio | 90% CI | ||
AUCτ, h ng/mL | 9 | 9116 (16.8) | 8136 (33.9) | 0.89 | 0.76, 1.05 |
Cmax, ng/mL | 9 | 1842 (31.1) | 1239 (23.3) | 0.67 | 0.55, 0.82 |
Cmin, ng/mL | 9 | 218.5 (30.3) | 262.3 (58.6) | NC | NC |
tmax, ha | 9 | 0.6 (0.5–4) | 2.0 (2–4.3) |
CV coefficient of variation, GLSM geometric least-squares mean, Gmean geometric mean, NC not calculated
aMedian (range)