Table 3.
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.