Average bioequivalence of two oral formulations of fluconazole in healthy subjects after multiple dosing

Citation
I. Atanasova et al., Average bioequivalence of two oral formulations of fluconazole in healthy subjects after multiple dosing, INT J CL PH, 37(6), 1999, pp. 282-285
Citations number
10
Categorie Soggetti
Pharmacology & Toxicology
Journal title
INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS
ISSN journal
09461965 → ACNP
Volume
37
Issue
6
Year of publication
1999
Pages
282 - 285
Database
ISI
SICI code
0946-1965(199906)37:6<282:ABOTOF>2.0.ZU;2-X
Abstract
Objectives: To assess the average bioequivalence of two oral dosage forms o f fluconazole - test (Fungolon, Antibiotic Co.) and reference (Diflucan, Pf izer) - in 18 healthy volunteers in a multiple dose-balanced, two-period, c rossover study design. Materials and methods: The dosage regimen consisted of seven days treatment (first day 100 mg and 50 mg thereafter for six days given orally) and a washout period of two weeks between different treatmen ts. Plasma samples were taken at regular time intervals according to the st udy protocol for measuring of plasma fluconazole concentrations. The primar y and secondary parameters AUC(168-192), C-av, %PTF, C-max, %Swing, %AUCF 1 00 C-max/AUC, T above C-av, and T-max were estimated. Results: The point es timates - geometric means of the ratios test (T)/reference (R) and the 90% confidence intervals (CI) for the ratios of expected medians (T)/(R), assum ing a multiplicative model, estimated by parametric and nonparametric analy sis - were in the defined ranges for accepting of bioequivalence for two of the primary metrics. The point estimates and the 90% CIs after parametric analysis of AUC168-192 were 1.00 (0.98 - 1.02) and for the metric %PTF exce eded the accepted range for bioequivalence after parametric analysis the po int estimate and 90% CI were 0.93 and (0.799 - 1.08). Conclusion:The two pr eparations were considered to be bioequivalent in the rate and extent of ab sorption with significant variability across subjects.