PHARMACOKINETICS AND BIOEQUIVALENCE OF DOMESTIC CAPSULE AND IMPORTED TABLET OF ISOSORBIDE 5-MONONITRATE IN HEALTHY VOLUNTEERS AFTER ORAL DOSING
Abstract：ECTIVE: To study the pharmacokinetics of domestic capsules and imported tablets of IS-5-MN in healthy volunteers and to determine the bioequivalence of the drug. METHODS:A single dose of 20 mg of the drug was given in a randomized two-period crossover study. Plasma drug concentration was assayed by GC with capillary columns. The data were processed with CAPP phar macokinetic pharmacodynamic procedure and the bioequivalence was calculated. RESULTS: The con
centration-time courses after medication conformed to a two-compartment open model. The Cmax Of domestic capsules and imported tablets were (477.7 ± 103.9) μg/L and (468.1 ± 107.8) μg/L respec tively; the Tmax of the above two preparations were (0.77 ± 0.36) h and (0.84 ± 0.24) h respectively and their elimination ti/2 were (6.99 ± 0.71) h and (7.02± 0.51).h respectively. The difference of the main pharmacokinetic parameters between the two formulations was nonsignificant (P> 0.05).
Keywords：Isosorbide 5-mononitratePharmacokineticsBioequivalenceBioavailability
Publication Date：1999-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 810-813 )