Voriconazole is a broad-spectrum antifungal agent belonging to the triazole class, exhibiting significant efficacy against a diverse array of pathogenic organisms. This study aimed to assess the pharmacokinetic properties, bioequivalence, and safety profiles of two oral formulations of voriconazole tablets. An open-label, randomized, two-period, two-sequence crossover, Phase I bioequivalence trial was conducted involving healthy Chinese volunteers under fasting conditions. During each study period, participants were administered a single 200 mg dose of either the generic (test) or branded (reference) voriconazole tablet, with treatment sequences assigned randomly. Blood samples were collected at various time points before and after administration to determine plasma voriconazole concentrations. The study assessed bioequivalence by calculating the maximum concentration (Cmax) and the area under the concentration-time curve (AUC). Adverse events (AEs) were systematically documented. A total of seventy healthy volunteers were recruited, with 68 participants who received voriconazole included in the final analysis. The geometric mean ratios (GMR) of the test tablet to the reference for Cmax, the area under the concentration curve from time 0 to the last measurable time point (AUC0-t), and the area under the concentration curve from time 0 extrapolated to infinity (AUC0-inf) were determined to be 1.03, 0.98, and 0.97, respectively, under fasting conditions. These values met the established criteria for bioequivalence acceptance. Furthermore, both the test and reference formulations of voriconazole were well tolerated. The findings indicate that the test and reference voriconazole tablets are bioequivalent and possess similar safety profiles in healthy Chinese volunteers.
Luo et al. (Wed,) studied this question.
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