Table 3.
Pharmacokinetics of VI
| Geometric mean (95% CI) | Ratio of adjusted geometric means (90% CI) | |||
|---|---|---|---|---|
|
| ||||
| Day 1 | Day 8 | Day 13 | ||
|
|
|
|
|
|
| UMEC/VI 500/25 μg N = 16 n = 16 |
UMEC/VI 500/25 μg N = 16 n = 15 |
UMEC/VI 500/25 μg + verapamil 240 mg N = 15 n = 15 |
UMEC/VI 500/25 μg + verapamil 240 mg vs UMEC/VI 500/25 μg | |
| AUC(0–0.25h) | NC | 38.9 (29.4, 51.4) | 38.9 (28.4, 53.3) | 1.08 (0.93, 1.27) |
| AUC(0–0.5h) | NC | 53.9 (36.3, 80.1) | 66.8 (50.3, 88.8) | 1.02 (0.90, 1.15) |
| AUC(0–2h) | NC | 78.3 (52.2, 117.6) | 105.5 (74.5, 149.5) | 1.14 (0.94, 1.37) |
| AUC(0–t) | NC | 63.9 (40.2, 101.8) | 87.2 (50.5, 150.6) | NC |
| Cmax(pg/mL) | 142.2 (98.1, 205.9) | 229.9 (174.8, 302.5) | 241.9 (196.4, 297.8) | 1.05 (0.90, 1.22) |
| tmax (h)a | 0.08 (0.08, 0.22) | 0.08 (0.08, 0.10) | 0.08 (0.08, 0.17) | NC |
| tlast (h)a | 0.08 (0.08, 0.22) | 0.53 (0.25, 2.00) | 1.00 (0.08, 8.00) | NC |
Note:
a
Presented as median and range.
Abbreviations: AUC(0–t), AUC from time 0 to time of last quantifiable concentration; AUC(0–x), area under the plasma concentration-time curve from time zero to a fixed time × (hours); CI, confidence interval; Cmax, maximum observed plasma concentration; NC, not calculated; tlast, last time point where the concentration was above the limit of quantification; tmax, time of maximum observed plasma concentration; UMEC, umeclidinium; VI, vilanterol.