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. 2021 May 1;10(9):1054–1063. doi: 10.1002/cpdd.937

Table 4.

Statistical Analysis Results of the Effect of Dabrafenib (Initial Dosing or Steady State) on Midazolam PK Parameters

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.

a

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).

b

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.