Pharmacokinetics
The mean blood concentration-time profiles of the two nifedipine
extended-release tablets after a single oral dose of 30 mg of the test
formulation and the reference formulation (under fasting conditions) are
shown in Figure 1 . The mean blood concentration-time profiles
of the two nifedipine extended-release tablets after a single oral dose
of 30 mg of the test formulation and the reference formulation (under
postprandial conditions) are shown in Figure 2 . The PK
parameters obtained from the test results in these subjects (46 fastings
and 48 postprandial) are shown in Table 1 , and the 90% CIs for
the geometric mean ratios of Cmax,
AUC0-t, and AUC0-∞, and the test
efficacy are shown in Table 2 . All the results are within the
acceptable equivalent range (80% ~ 125%).