[Translation] A single-center, randomized, open-label, two-dose, single-dose, four-period, completely repeated crossover fasting bioequivalence study of levothyroxine sodium tablets in healthy subjects
主要目的:以药代动力学参数作为主要终点评价指标,比较在空腹条件下口服受试制剂左甲状腺素钠片(生产厂家:由上海葆隆生物科技有限公司委托江苏云阳集团药业有限公司生产)与参比制剂左甲状腺素钠片(持证商:Merck Healthcare Germany GmbH,商品名:Euthyrox®)后在健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。 次要目的:观察受试制剂左甲状腺素钠片和参比制剂左甲状腺素钠片在健康受试者中的安全性。
[Translation] Primary objective: To compare the pharmacokinetic behavior of the test preparation Levothyroxine Sodium Tablets (manufacturer: Shanghai Baolong Biotechnology Co., Ltd., Jiangsu Yunyang Group Pharmaceutical Co., Ltd.) and the reference preparation Levothyroxine Sodium Tablets (licensed by Merck Healthcare Germany GmbH, trade name: Euthyrox®) in healthy subjects after oral administration under fasting conditions, using pharmacokinetic parameters as the primary endpoint evaluation indicators, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation Levothyroxine Sodium Tablets and the reference preparation Levothyroxine Sodium Tablets in healthy subjects.