Observed-versus-predicted mean (SD) of Cmax and AUC0–24 of clopi-H4 without and with dronedarone coadministration (400 mg BID) at day 1 (300-mg loading dose) and at day 5 (75-mg last maintenance dose)
Data are presented as mean (S.D.).
| Parameter | Without dronedarone | With dronedarone | ||
|---|---|---|---|---|
| Obs. (n = 63) | Sim. (n = 100) | Obs. (n = 63) | Sim. (n = 100) | |
| Day 1 (300-mg clopidogrel loading dose) | ||||
| Cmax (ng/ml) | 17.0 (10.5) | 16.8 (10.6) | 17.6 (14.2) | 12.1 (6.82) |
| AUC0–24 (ng ⋅ h−1 ⋅ ml−1) | 37.9 (19.2) | 59.5 (37.4) | 43.1 (27.9) | 43.2 (26.5) |
| Day 5 (last 75-mg clopidogrel last maintenance dose) | ||||
| Cmax (ng/ml) | 6.63 (4.08) | 6.56 (4.43) | 5.21 (2.89) | 4.66 (2.95) |
| AUC0–24 (ng.h−1 ⋅ ml−1) | 12.8 (5.12) | 20.4 (13.5) | 14.2 (8.11) | 14.7 (9.67) |