[Translation] A randomized, open-label, single-dose, two-sequence, two-period, crossover bioequivalence study of betahistine hydrochloride tablets (8 mg) in Chinese healthy volunteers under fasting and fed conditions
主要目的: 本研究以北京京丰制药集团有限公司提供的盐酸倍他司汀片(生产单位:北京京丰制药集团有限公司 规格:8mg)为受试制剂,以北京京丰制药集团有限公司提供的盐酸倍他司汀片(持证商:Mylan Products Ltd.,商品名为:Serc 规格:8mg)为参比制剂,评估受试制剂和参比制剂在空腹和餐后条件下的生物等效性。
次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary Objective: This study evaluated the bioequivalence of the test and reference formulations under fasting and fed conditions using Betahistine Hydrochloride Tablets (manufactured by Beijing Jingfeng Pharmaceutical Group Co., Ltd., strength: 8 mg) and Betahistine Hydrochloride Tablets (licensed by Mylan Products Ltd., trade name: Serc, strength: 8 mg) provided by Beijing Jingfeng Pharmaceutical Group Co., Ltd. as the test formulation and Betahistine Hydrochloride Tablets (licensed by Mylan Products Ltd., trade name: Serc, strength: 8 mg) as the reference formulation.
Secondary Objective: To observe the safety of the test and reference formulations in healthy volunteers.