Table 1.

PK Parameters over All Subjects for BI 695501 via PFS or AI

ParameterPFSAIAdjusted gMean ratio (AI/PFS)*2-sided 90% CI*
nAdjusted gMean*nAdjusted gMean*
AUC0–∞ [μg·h/mL]352270352280100.2282.13, 122.29
AUC0–1032 [μg·h/mL]351960351960100.1485.15, 117.76
Cmax [μg/mL]363.76354.14110.1996.80, 125.44
  • *Adjusted for treatment and BMI group as fixed effects; Based on observed last concentration values; AUC values could not be calculated for one subject (Subject 1001-0110), due to the lack of appropriate terminal phase (only one non-BLQ [below the limit of quantification] value in the elimination phase).