Table 3.
Comparison of Pharmacokinetic Parameters of Fimasartan and Atorvastatin After a Single Administration of FDC of Fimasartan 120mg/Atorvastatin 40mg or Loose Combination of Fimasartan 120mg+Atorvastatin 40mg
| Drug | Parameter | Geometric Mean | Geometric Mean Ratio (90% CI) | Intra-Subject CV% | Expanded 90% CI | |
|---|---|---|---|---|---|---|
| Fimasartan 120mg/ Atorvastatin 40mg (N=56) | Fimasartan 120mg + Atorvastatin 40 mg (N=56)a | |||||
| Fimasartan | Cmax (μg/L) | 332.92 | 309.57 | 1.0754 (0.9317–1.2414) | 60.56 | 0.6539–1.5293 |
| AUClast (h*μg/L) | 898.84 | 881.21 | 1.0200 (0.9672–1.0758) | 19.18 | ||
| Atorvastatin | Cmax (μg/L) | 37.05 | 36.38 | 1.0184 (0.9150–1.1334) | 44.14 | 0.7257–1.3780 |
| AUClast (h*μg/L) | 102.12 | 100.06 | 1.0204 (0.9748–1.0682) | 16.66 | ||
Note: aThe pharmacokinetic parameters are the sum of PK data collected after the first and second co-administration of fimasartan 120 mg + atorvastatin 40mg in 56 subjects.