Pharmacokinetics and Relative Bioavailability of Lisinopril Tablets
Xiaojin Shi
Abstract
Xiaojin Shi
Abstract
According to a randomized crossover design, the pharmacokinetics and relative bioavailability of test and reference tablets of lisinopril were investigated in 10 healthy male volunteers. The concentrations of lisinopril in plasma were determined by LC-MS/MS. The pharmacokinetic parameters for the test and reference tablets were cmax(58.2±21.5) and (54.6±16.6)ng·ml-1, tmax (7.3±1.5) and (7.0±1.6)h, AUC0-48(1025.5±501.7) and (849.0± 218.9)ng·h·ml-1, respectively. The relative bioavailability of the test tablets was (116.89±44.48)%. The results of 90% confi dence interval and two one-sided t-test showed that there were no signifi cant difference between the reference and test formulations in the AUC and Cmax, and the two formulations were bioequivalent.
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According to a randomized crossover design, the pharmacokinetics and relative bioavailability of test and reference tablets of lisinopril were investigated in 10 healthy male volunteers. The concentrations of lisinopril in plasma were determined by LC-MS/MS. The pharmacokinetic parameters for the test and reference tablets were cmax(58.2±21.5) and (54.6±16.6)ng·ml-1, tmax (7.3±1.5) and (7.0±1.6)h, AUC0-48(1025.5±501.7) and (849.0± 218.9)ng·h·ml-1, respectively. The relative bioavailability of the test tablets was (116.89±44.48)%. The results of 90% confi dence interval and two one-sided t-test showed that there were no signifi cant difference between the reference and test formulations in the AUC and Cmax, and the two formulations were bioequivalent.
Key concepts: Bioequivalence, Bioavailability, Cmax, Pharmacokinetics, Lisinopril, Chemistry, Crossover study, Pharmacology