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. 2020 Sep 17;9(8):952–960. doi: 10.1002/cpdd.868

Table 3.

Dose Proportionality Analysis of AUC and Cmax for Baricitinib Following Single Oral Doses of 2 to 10 mg on Day 1 and Multiple Oral Doses of 2 to 10 mg on Day 10 in Healthy Chinese Subjects

Single Oral Doses of 2 to 10 mg on Day 1
Parameter Power Model Equation 90%CI of Exponent Baricitinib Dose (mg) Predicted Dose‐Normalized Geometric Means Ratio of Dose‐Normalized Geometric Means (10 or 4 mg vs 2 mg) (90%CI)
AUC0‐∞, ng · h/mL (e4.16):(Dose1.08) 1.01‐1.14 2 67.43
4 71.03 1.05 (1.00‐1.11)
10 76.09 1.13 (1.01‐1.26)
Cmax, ng/mL (e2.37):(Dose1.12) 0.96‐1.28 2 11.67
4 12.71 1.09 (0.97‐1.22)
10 14.23 1.22 (0.94‐1.58)
Multiple oral doses of 2 to 10 mg on Day 10
AUCτ,ss, ng . h/mL (e4.21):(Dose1.04) 0.96‐1.13) 2 69.44
4 71.60 1.03 (0.97‐1.09)
10 74.56 1.07 (0.94‐1.23)
Cmax,ss, ng/mL (e2.59):(Dose0.99) 0.87‐1.22 2 13.25
4 13.17 0.99 (0.91‐1.08)
10 13.07 0.99 (0.81‐1.20)

AUC, area under the plasma concentration–time curve; AUC0‐∞, area under the plasma concentration–time curve from time zero to infinity; AUCτ,ss, area under the plasma concentration–time curve during one dosing interval at steady state; CI, confidence interval; Cmax, maximum observed drug concentration; Cmax,ss, maximum observed drug concentration at steady state.

Model: Log (Parameter) = Log (Dose) + Random Error.