Table 4.
PK Parametera | Treatment Comparisonb | Ratio or Difference (90%CI) |
---|---|---|
AUC0‐∞, ng • h/mL | B:A | 1.00 (0.78 to 1.29) |
C:A | 0.35 (0.27 to 0.45) | |
Cmax, ng/mL | B:A | 0.99 (0.81 to 1.22) |
C:A | 0.53 (0.43 to 0.66) | |
tmax, h | B−A | −0.12 (−0.13 to 0) |
C−A | −0.13 (−0.25 to 0) |
AUC, area under the concentration‐time curve; AUC0‐∞, AUC from time 0 (predose) extrapolated to infinite time; CI, confidence interval; Cmax, maximum observed concentration; PK, pharmacokinetics; tmax, time to Cmax.
Ratio of Cmax and AUC is the geometric least squares mean of test versus reference (90%CI); ratio of tmax is the median difference (90%CI).
Treatments A, B, and C were as follows:
(A) Single doses of rosuvastatin 10 mg + midazolam 3 mg on PK day 1.
(B) Single doses of rosuvastatin 10 mg + midazolam 3 mg + dabrafenib 150 mg twice daily at initial dosing on PK day 8.
(C) Single doses of rosuvastatin 10 mg + midazolam 3 mg + dabrafenib 150 mg twice daily at steady state on PK day 22.