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
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.