Title: Pharmacokinetics and bioequivalence of domestic and imported lisinopril tablets in healthy volunteers
Abstract: Objective To evaluate the bioequivalence of domestic lisinopril tablets and imported tablets in healthy volunteers.Methods A single oral dose of 20 mg domestic and imported lisinopril tablets was given to 20 healthy volunteers in a randomized crossover study.Lisinopril concentrations in plasma were determined by HPLC-MS/MS methods.Results The main pharmacokinetic parameters of the domestic and imported tablets were as follow: tmax were(6.00±0.46),(6.35±0.88) h;Cmax were(81.47±40.92),(80.91±37.45) ng·mL-1;t1/2 were(10.99±6.12),(10.71±3.40) h;AUC0-48 were(784.90±379.40),(815.40±377.60) ng·h·mL-1;AUC0-∞ were(838.50±392.00),(868.00±392.2) ng·h·mL-1,respectively.The relative bioavailability of domestic lisinopril tablets to imported tablets was(97.1±11.9)%.Conclusion The results demonstrated that the two preparations were bioequivalent.
Publication Year: 2010
Publication Date: 2010-01-01
Language: en
Type: article
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