[Translation] An open-label, single-dose, randomized, four-period, two-sequence, completely repeated, single-center, phase I study to evaluate the bioequivalence of 12 oral tablets of 50 μg levothyroxine sodium produced by Merck Nantong and 50 μg levothyroxine sodium (Euthyrox) produced by Merck Darmstadt in healthy subjects
主要目的:评价默克南通生产的左甲状腺素钠片(受试制剂)与默克达姆施塔特生产的左甲状腺素钠片(优甲乐)(参比制剂)之间的BE
次要目的:研究血清中总甲状腺素(T4)的药代动力学(PK);研究血清中总三碘甲状腺原氨酸(T3)的PK;评估600 μg 左甲状腺素钠单次给药的安全性和耐受性
[Translation] Primary objective: To evaluate the BE between levothyroxine sodium tablets (test product) produced by Merck Nantong and levothyroxine sodium tablets (Euthyrox) (reference product) produced by Merck Darmstadt
Secondary objectives: To study the pharmacokinetics (PK) of total thyroxine (T4) in serum; To study the PK of total triiodothyronine (T3) in serum; To evaluate the safety and tolerability of a single dose of 600 μg levothyroxine sodium