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+Clast/λz(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.