Pharmacokinetic and bioequivalence study of two gemfibrozil preparations

Sarolta Benkö, Sándor Drabant, Gyula Grézal, Iván Ürmös, Margit Csörgö, Imre Klebovich

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Abstract

A comparative pharmacokinetic study has been performed in 19 healthy male volunteers in a single-dose, randomized, two way cross-over design with two preparations of gemfibrozil (CAS 25812-30-0) capsules each of them containing 300 mg active ingredient. The test preparation was Innogem® 300 mg capsule. The plasma concentration of gemfibrozil was determined by a validated HPLC-UV analytical method. The statistical comparison of individual pharmacokinetic parameters (AUC0-16, AUC(0-∞), C(max), t(max)) Of the two capsule preparations was performed by three-way analysis of variance (ANOVA), Wilcoxon's, Westlake's, Schuirmann's and Hauck-Anderson's method as well as by the calculation of confidence intervals on the ratio of test/reference. The relativ bioavailability of the test preparation with respect to the reference preparation in terms of the AUC(0-∞) was 104.06 ± 21.61%. No statistically significant difference was found between the pharmacokinetic parameters, calculated from plasma concentration-time curves, indicating that the two preparations were bioequivalent.

Original languageEnglish
Pages (from-to)913-916
Number of pages4
JournalArzneimittel-Forschung/Drug Research
Volume47
Issue number8
Publication statusPublished - Sep 6 1997

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Keywords

  • Antihyperlipaemic drug
  • Bioequivalence
  • CAS 25812-30-0
  • Clinical studies
  • Gemfibrozil
  • Innogem®
  • Pharmacokinetics

ASJC Scopus subject areas

  • Drug Discovery

Cite this

Benkö, S., Drabant, S., Grézal, G., Ürmös, I., Csörgö, M., & Klebovich, I. (1997). Pharmacokinetic and bioequivalence study of two gemfibrozil preparations. Arzneimittel-Forschung/Drug Research, 47(8), 913-916.