Data analysis

Data Analysis: PK parameters:

The disposition of Captopril following oral administration will be characterized according to the following equation for a one compartment model with an absorption phase and an elimination phase: C_p = (F.D/V)[Ka/(Ka-K)[ {exp[-K(t-t_lag)], where F is the fraction of administered dose which is bioavailable, D is the administered dose, V is the apparent volume of distribution, and the other terms are as defined above . The PK data fitting program Phoenix WinNonlin (Version 6.2 or higher), or a suitable alternative, will be used to fit the data according to this equation.

The following PK parameters will be calculated:

• AUC_last will be calculated using the linear  trapezoidal rule
• AUC_inf will be estimated as the sum of AUC_last and the terminal area determined from C_last/T_last.
• C_max, and T_max, will be observed maximum drug concentration and the corresponding times, respectively
• T1/2 will be estimated from the terminal elimination phase drug concentration-time date using standard PK procedures. Data will be summarized as mean [95% confidence interval) except for age, C_max and T_max, which will be expressed as median (range).

Safety parameters:

Descriptive statistics of subjects’ safety data will be carried out. The number and percentage of subjects with adverse events will be tabulated by system organ class and preferred term.