Pharmacokinetic Analysis
Pharmacokinetic (PK) parameters for lisinopril and amlodipine in plasma were estimated by a non-compartmental model (NCA) using Phoenix WinNonlin version 7.0 software (Pharsight Corporation, St Louis, MO, USA). For the purpose of bioequivalence analysis, the maximum observed concentration (Cmax), the area under the plasma concentration-time curve from time 0 to the last measured time point (AUC0-t), and the area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)were considered as primary PK parameters. The secondary PK parameters were the observed time to Cmax(Tmax) and the apparent terminal half-life (T1/2). Cmax and Tmaxwere the factually measured data andAUC0-t was calculated using the linear and logarithmic trapezoidal methods. AUC0-∞ was calculated according to the following formula: AUC0-∞= AUC0-t+Clastz(Clastis the last measurable concentration and is the first order rate constant of terminal elimination determined from a linear regression line after logarithmic transformation at the end of concentration time curve. λzis the slope calculated by linear regression after logarithmic conversion at the end of the concentration-time curve). T1/2 was calculated to be ln2/λ.