Bioequivalence of Fluconazole in Health Volunteers
- VernacularTitle:氟康唑片在健康人体内的生物等效性研究
- Author:
Yuhui WANG
- Publication Type:Journal Article
- Keywords:
Fluconazole;
HPLC;
Pharmacokinetics;
Bioequivalence
- From:
China Pharmacy
2001;0(11):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the bioequivalence of fluconazole in healthy volunteers.METHODS:By a randomized double crossover design,a total of 20 healthy male volunteers were assigned to receive oral single dose of test fluconazole tablets (300 mg) and reference fluconazole tablets(300 mg).The plasma concentrations of fluconazole at different time after oral ad- ministration were determined by HPLC,with pharmacokinetic parameters computed and the bioequivalence of the two formu- lations of fluconazole evaluated.RESULTS:The pharmacokinetic parameters of test fluconazole tablets vs.the reference flu- conazole tablets were as follows:t_(1～2):(29.98?4.79)hvs.(30.60?4.66)h,t_(max):(1.9?0.3)hvs.(1.9?0.6)h;C _(max):(7.64?0.98)?g?mL~(-1)vs.(7.93?0.78)?g?mL~(-1) AUC_(0～96):(258.41?36.49)?g?h?mL~(-1)vs.(267.93?31.24)?g?h?mL~(-1) AUC_(0～∞):(283.17?45.80)?g?h?mL~(-1)vs.(299.70?38.41)?g?h?mL~(-1) and derived from planimetry AUC_(0～96) and AUC_(0～∞),the relative bioavailability of the test tablet were(94.9?11.3)%and(94.8?11.9)%,respectively.CONCLUSION: The test fluconazole tablets and the reference fluconazole tablets were proved to be bioequivalent.
