Pharmacokinetics and bioequivalence of domestic and imported lisinopril tablets in healthy volunteers

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Pharmacokinetics and bioequivalence of domestic and imported lisinopril tablets in healthy volunteers

Published Jan 1, 2010 · L. Ting-li

The Chinese Journal of Clinical Pharmacology

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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.

RCT

Study Snapshot

Domestic and imported lisinopril tablets are bioequivalent in terms of pharmacokinetic parameters and bioavailability in healthy volunteers.

PopulationOlder adults (50-71 years)

Sample size24

MethodsObservational

OutcomesBody Mass Index projections

ResultsSocial networks mitigate obesity in older groups.

Pharmacokinetics and bioequivalence of domestic and imported lisinopril tablets in healthy volunteers

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