[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover bioequivalence pre-trial of pyridostigmine bromide tablets (60 mg) in healthy trial participants under fasting administration conditions.
主要目的:通过小样本量空腹预试验研究,考察中国健康试验参与者在空腹条件下单剂量口服上海上药中西制药有限公司提供的溴吡斯的明片(规格:60mg)与持证商为Mylan Products Ltd的溴吡斯的明片(商品名:Mestinon®,规格:60mg)制剂的相似程度,考察药物的体内药代动力学特征及个体内变异系数,为能否进入正式试验提供决策依据,并验证正式试验样本量、采血点及试验周期间隔等设置的合理性。
次要目的:评价单剂量口服溴吡斯的明片(规格:60mg)受试制剂及参比制剂在中国健康试验参与者中的安全性。
[Translation] Primary Objective: To investigate the similarity between a single oral dose of pyridostigmine bromide tablets (60 mg) supplied by Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd. and the pyridostigmine bromide tablets (trade name: Mestinon®, 60 mg) manufactured by Mylan Products Ltd., under fasting conditions, in healthy Chinese participants through a small-sample, fasting pre-trial study. The study will examine the pharmacokinetic characteristics and intra-individual coefficient of variation of the drugs, providing a basis for decision-making regarding inclusion in the formal trial, and verifying the rationality of the sample size, blood collection points, and trial intervals in the formal trial.
Secondary Objective: To evaluate the safety of a single oral dose of pyridostigmine bromide tablets (60 mg) in both the test and reference formulations in healthy Chinese participants.