Jilin Boda Weiye Pharmaceutical Co. Ltd.

The in vivo pharmacokinetic characteristics of pyridostigmine bromide tablets (test preparation, T, 60 mg) provided by Jilin Boda Weiye Pharmaceutical Co., Ltd. and pyridostigmine bromide tablets (reference preparation, R, 60 mg) from the licensed manufacturer Valeant Pharmaceuticals North America LLC were investigated in healthy Chinese subjects after a single oral dose under fasting conditions, and bioequivalence evaluation was performed.

The in vivo pharmacokinetic characteristics of pyridostigmine bromide tablets (test preparation, T, 60 mg) provided by Jilin Boda Weiye Pharmaceutical Co., Ltd. and pyridostigmine bromide tablets (reference preparation, R, 60 mg) from the licensed manufacturer Valeant Pharmaceuticals North America LLC were investigated in healthy Chinese subjects after a single oral dose under fasting/postprandial conditions, and bioequivalence evaluation was performed.

Main study objectives To study the pharmacokinetic characteristics of the test preparation T (Poprezinc granules 75 mg/bag, produced by Jilin Boda Weiye Pharmaceutical Co., Ltd.) and the reference preparation R (Poprezinc granules Promac ®, 75 mg/bag, produced by ZERIA Pharmaceutical Industry Co., Ltd.) in healthy subjects after a single oral administration under fasting conditions, and to evaluate the bioequivalence of the two preparations when taken orally under fasting conditions. Secondary study objectives To evaluate the safety of the test preparation T and the reference preparation R in healthy subjects.