Abstract

Aim: To determine the bioequivalence of two oral formulations of generic fluconazole in twelve healthy Thai volunteers. Subjects, materials and 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 Diflucan (1.59 ± 0.54). The 90% confidence intervals of the AUC0-¥ ratio and the Cmax ratio mT/mR 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 AUC0-¥ and Cmax, respectively. Conclusion: Thus, our study demonstrated the bioequivalence of Flucozole and Diflucan with respect to the rate (Cmax) and extent of absorption (AUC0-¥).

Author Details

Authors

• M. Manorot
• N. Rojanasthien
• B. Kumsorn
• S. Teekachunhatean

Departments

• Division of Clinical Pharmacology, Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Thailand

Address

Dr. N. Rojanasthein; Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

Citation