[Translation] A randomized, open-label, single-dose, two-dose, two-sequence, two-cycle, crossover bioequivalence trial of voriconazole tablets in healthy subjects
主要目的:比较空腹单次给药条件下,武汉启瑞药业有限公司生产的伏立康唑片(规格:200mg,受试制剂),与Pfizer Italia S.r.l.生产的的伏立康唑片(规格:200mg)在健康受试者中药动学指标的差异。通过主要药动学参数,评价两制剂的生物等效性。
次要目的:观察健康受试者单次空腹口服受试制剂和参比制剂的安全性指标,评价伏立康唑片的安全性。
[Translation] Main purpose: To compare the voriconazole tablets (specification: 200mg, test preparation) produced by Wuhan Qirui Pharmaceutical Co., Ltd. and the voriconazole tablets (specification: 200mg) produced by Pfizer Italia S.r.l. in healthy subjects under the condition of single administration on an empty stomach. Differences in Chinese pharmacokinetic indicators among subjects. The bioequivalence of the two preparations was evaluated by the main pharmacokinetic parameters.
Secondary objective: To observe the safety indexes of the test preparation and the reference preparation by single fasting oral administration in healthy subjects, and to evaluate the safety of voriconazole tablets.