Clinical pharmacokinetics and bioavailability study between generic and branded fluconazole capsules
Fluconazole is an effective bis-triazole oral antifungal agent indicated for the treatment of systemic and superficial candidiasis. The clinical pharmacokinetics and relative bioavailability (bioequivalence) of a single dose of new generic formula (capsule) containing 150 mg fluconazole as a test product was compared against the brand product Diflcan® 150 mg capsule, Pfizer, as a reference product. Both products were administered to 28 healthy Arabic adult males applying fasting, a two-sequence, two-period, two-treatment, single-dose, randomized crossover design with two weeks washout interval between dosing. Eighteen blood samples were taken from each subject before dosing (time zero) and then at 0.33, 0.67, 1.0, 1.33, 1.67, 2.0, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, and eventually at 120 hours post-dosing. From plasma concentrations obtained from each participant, the pharmacokinetic parameters; Kelimination (lz), AUC0–t, Tmax, Cmax, AUC0–∞, Thalf and MRT were calculated by non-compartmental analysis and statistically analyzed using ANOVA. Ln-transformed values of the parameters used for bioequivalence evaluation namely Cmax, AUC0–t, and AUC0–∞ were also statistically analysed by ANOVA and 90% confidence interval tests. For Tmax and MRT, nonparametric tests were performed. Based on EMEA and FDA criteria on bioequivalence, the results showed bioequivalence of the 2 products. Both drug products were well tolerated by all participants. Thus, the new generic fluconazole 150 mg capsule can be interchangeable with Diflcan® capsule and may be prescribable in clinical practice.
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