Pharmacokinetics and bioequivalence testing of generic fluconazole preparations in healthy thai volunteers.
OBJECTIVE
To determine the bioequivalence of two oral formulations of generic fluconazole in twelve healthy Thai volunteers.


METHODS
The test preparation was Flucozole (Siam Bheasach, Thailand) and the reference was Diflucan (Pfizer Inc.). The two products were administered as 200 mg single oral doses in a two-period crossover design with a two-week washout period. After drug administration, serial blood samples were collected over a period of 72 hours. Serum fluconazole concentrations were determined by HPLC, and the pharmacokinetic parameters were analyzed by non-compartmental analysis.


RESULTS
The time to reach the maximal concentration (Tmax, hour) of Flucozole (1.18 +/- 0.56) was statistically faster than that of Diflulan (1.59 +/- 0.54). The 90% confidence intervals of the AUC(0 - infinity) ratio and the Cmax, ratio muT/muR for Flucozole/Diflucan were 0.97 - 1.20 and 1.01 - 1.26, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25 and 0.7 - 1.43 for the ratio of the average AUC(0 - infinity) and Cmax, respectively.


CONCLUSIONS
Thus, our study demonstrated the bioequivalence of Flucozole and Diflucan with respect to the rate (Cmax) and extent of absorption (AUC(0 - infinity).
Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Thailand.
M
M
Manorot
N
N
Rojanasthien
B
B
Kumsorn
S
S
Teekachunhatean
D000328:Adult; D000935:Antifungal Agents / Q000493:pharmacokinetics*; D019540:Area Under Curve; D018592:Cross-Over Studies; D004311:Double-Blind Method; D016568:Drugs, Generic; D005260:Female; D015725:Fluconazole / Q000493:pharmacokinetics*; D006801:Humans; D008297:Male; D008954:Models, Biological; D013785:Thailand; D013810:Therapeutic Equivalency
D000935:Antifungal Agents; D016568:Drugs, Generic; D015725:Fluconazole