TABLE 3

Observed-versus-predicted ratio estimates (90% CI) of Cmax and AUC0–24 for clopidogrel and clopi-H4 without and with dronedarone coadministration (400 mg BID) at day 1 (300-mg loading dose) and at day 5 (75-mg maintenance dose)

ParameterClopidogrelSecondary metabolite (clopi-H4)
Observed (n = 63)Simcyp (n = 100)Observed (n = 63)Simcyp (n = 100)
Ratio estimate (90% CI) at day 1 (300-mg clopidogrel loading dose)
Cmax0.89 (0.80–0.99)1.01 (1.01–1.01)0.93 (0.84–1.04)0.72 (0.71–0.76)
 AUC0–241.00 (0.94–1.07)1.00 (1.00–1.00)1.09 (0.65–1.20)0.73 (0.72–0.76)
Ratio estimate (90% CI) at day 5 (75-mg clopidogrel maintenance dose)
Cmax0.96 (0.85–1.08)1.00 (1.00–1.00)0.81 (0.73–0.89)0.72 (0.71–0.75)
 AUC0–241.03 (0.96–1.11)1.00 (1.00–1.00)1.05 (0.67–1.22)0.72 (0.71–0.76)
  • CI, confidence interval.