TABLE 3.
Statistical analysis of dose-normalized omadacycline pharmacokinetic parameters on days 1 and 5 of dosinga
Day and parameter | Treatment (mg) | n | Geometric LS means | Treatment comparison | Ratio of geometric LS means (%) | 90% CI of ratio |
---|---|---|---|---|---|---|
Day 1 | ||||||
AUC0–24/dose, ng · h/ml/mg | 300 | 25 | 21.32 | |||
450 | 24 | 18.64 | 450/300 | 87.44 | 77.41–98.77 | |
600 | 24 | 16.18 | 600/450 | 86.79 | 76.71–98.20 | |
600/300 | 75.89 | 67.20–85.71 | ||||
Cmax/dose, ng/ml/mg | 300 | 25 | 2.09 | |||
450 | 24 | 1.81 | 450/300 | 86.71 | 76.17–98.71 | |
600 | 24 | 1.54 | 600/450 | 85.26 | 74.76–97.23 | |
600/300 | 73.92 | 64.95–84.14 | ||||
Day 5 | ||||||
AUC0–24/dose, ng · h/ml/mg | 300 | 23 | 30.09 | |||
450 | 24 | 28.83 | 450/300 | 95.82 | 90.39–101.59 | |
600 | 23 | 26.46 | 600/450 | 91.78 | 86.58–97.30 | |
600/300 | 87.95 | 82.96–93.25 | ||||
Cmax/dose, ng/ml/mg | 300 | 23 | 2.62 | |||
450 | 24 | 2.32 | 450/300 | 88.58 | 83.19–94.32 | |
600 | 23 | 2.11 | 600/450 | 90.72 | 85.20–96.60 | |
600/300 | 80.36 | 75.47–85.58 |
Results are for PK population and were determined by ANOVA; see Materials and Methods for details. One subject during 300-mg omadacycline dosing and 1 subject during 600-mg omadacycline dosing vomited before reaching PK steady state on day 5. These subjects met criteria for exclusion from PK analyses and are not included in the day 5 summary. CI, confidence interval; LS, least squares.