[Translation] An open-label, prospective, single-dose, randomized, two-sequence, four-period, fully repeated, single-center, phase I comparative study in healthy subjects to evaluate the bioequivalence of 12 tablets of 50 μg Euthyrox® produced by Merck (Nantong) and 50 μg Euthyrox® produced by Merck (Darmstadt) after oral administration
主要目的:
评价默克(南通)工厂生产的优甲乐片(受试制剂)与默克(达姆施塔特)工厂生产的优甲乐片(参比制剂)之间的生物等效性 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;
评估单次给与 600 μg优甲乐的安全性和耐受性。
[Translation] Primary objective:
To evaluate the bioequivalence between Euthyrox tablets (test product) produced by Merck (Nantong) and Euthyrox tablets (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 Euthyrox.