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Evaluation of Bioavailability and Pharmacokinetics of Two Isosorbide‐5‐Mononitrate Preparations in Healthy Volunteers
Author(s) -
Hutt V.,
Theodor R.,
Pabst G.,
Bonn R.,
Fritschi E.,
Jaeger H.
Publication year - 1992
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1177/009127009203200611
Subject(s) - bioequivalence , bioavailability , pharmacokinetics , isosorbide mononitrate , medicine , pharmacology , plasma concentration , oral administration , confidence interval , concomitant , chromatography , chemistry , anesthesia
The objective of this study was to determine both the pharmacokinetic parameters and the bioavailability of two commercial 20‐mg isosorbide‐5‐mononitrate (IS‐5‐MN) preparations (test and reference preparation) after single oral administration. For this purpose, the test and the reference preparation were examined in 24 healthy male volunteers according to a randomized 2‐way cross‐over design, blood samples were withdrawn up to 24 hours postadministration, and plasma concentrations of IS‐5‐MN were quantified by a gas chromatography (GC) method. Both preparations led to peak plasma levels of approximately 360 ng/mL IS‐5‐MN in the mean 0.76 hour (test) and 0.94 hour (reference preparation) after application; the plasma half‐lives were about 5.2 hours, and for the areas under the curve (AUC(0‐∞)), mean values of 2741 (test preparation) and 2742 hour · ng/mL (reference preparation) were found. The statistical comparison (analysis of variance, confidence intervals) of the pharmacokinetic parameters found in the study resulted in bioequivalence of both IS‐5‐MN preparations. The undesired side effects/concomitant symptoms observed are known to occur after IS‐5‐MN administration.