艾立康药业股份有限公司

To investigate the pharmacokinetic characteristics of healthy subjects after a meal when a single oral dose of one tablet of Betahistine Mesylate Tablets [test preparation, strength: 6 mg] provided by Anhui Aili Pharmaceutical Co., Ltd. is taken compared with a single oral dose of one tablet of Betahistine Mesylate Tablets [reference preparation, trade name: Minshilang®, strength: 6 mg] certified by Eisai (China) Pharmaceuticals Co., Ltd., to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Primary Study Objective: In accordance with relevant bioequivalence testing regulations, Pinaverium Bromide Tablets (trade name: Dicetel, strength: 50 mg), licensed by Abbott Laboratories Limited, were selected as the reference preparation. A human bioequivalence study was conducted against the test preparation, Pinaverium Bromide Tablets (strength: 50 mg), produced and provided by Anhui Aili Pharmaceutical Co., Ltd., under both fasting and fed conditions. The study aimed to compare the drug absorption rate and extent of the test preparation with those of the reference preparation to determine if they were within acceptable limits, and to evaluate the bioequivalence of the two preparations under both fasting and fed conditions. Secondary Study Objective: To observe the safety of oral administration of the test preparation, Pinaverium Bromide Tablets (strength: 50 mg), and the reference preparation, Pinaverium Bromide Tablets (trade name: Dicetel, strength: 50 mg), in healthy volunteers.

Main research purpose: According to the relevant provisions of bioequivalence test, Zambon S.p.A. was selected as the reference preparation, and the test preparation Safinamide Mesylate Tablets (Specification: 100 mg) produced and provided by Anhui Aili Pharmaceutical Co., Ltd. was used for postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions. Secondary research purpose: To observe the safety of the test preparation Safinamide Mesylate Tablets (Specification: 100 mg) and the reference preparation Safinamide Mesylate Tablets (Trade Name: Xadago, Specification: 100 mg) taken orally by healthy subjects.