| Title | Evaluation of the bioequivalence and pharmacokinetics of two lisinopril tablet formulations after single oral administration in healthy volunteers. | | Author(s) | Georgarakis M, Tsakalof A, Zougrou F, Kontopoulos G, Tsiptsios I | | Institution | Laboratory of Pharmaceutics and Drug Control, Department of Pharmacy, Aristotle University of Thessaloniki, Thessaloniki, Greece. mgeorgara@hotmail.com | | Source | Arzneimittelforschung 2004; 54(1):15-9. | | MeSH | Adult
Angiotensin-Converting Enzyme Inhibitors
Area Under Curve
Chromatography, High Pressure Liquid
Comparative Study
Cross-Over Studies
Female
Half-Life
Humans
Lisinopril
Male
Spectrum Analysis, Mass
Tablets
Therapeutic Equivalency
| | Abstract | An open, two-period, randomized, crossover trial of two lisinopril (1-[N2-[(S)-1-carboxyl-3-phenylpropyl]-L-lysil]-L-proline, CAS 76547-98-3) formulations (Adicanil as test and another commercially available preparation as reference) was performed in 24 healthy volunteers. A single 20 mg oral dose of lisinopril was administrated and pharmacokinetic parameters were compared. Lisinopril plasma concentrations were measured by a fully validated LC-MS method. The parametric 90% confidence intervals of the geometric mean values of the test/reference ratios were 95.38% to 105.94% (point estimate: 100.52%) for AUC(0-last), 94.01% to 103.47% (point estimate: 98.63%) for AUC(0-infinity) and 92.34% to 103.97% (point estimate: 97.98%) for Cmax, being within the acceptance criteria for bioequivalence (80%-125%). T(1/2), k(el) and Tmax values were also tested and the difference was not statistically significant. Therefore, it is concluded that the test and the reference lisinopril formulations are bioequivalent both in the extent and the rate of absorption. | | Language | eng | | Pub Type(s) | Clinical Trial
Journal Article
Randomized Controlled Trial
| | PubMed ID | 14979604 |
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