盐酸倍他司汀片(8mg)在中国成年健康受试者中餐后给药条件下随机、开放、单剂量、两序列、两周期、交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, crossover bioequivalence study of betahistine hydrochloride tablets (8 mg) in healthy Chinese adult subjects after meal administration
主要目的:本研究以安徽均大高科医药科技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,以安徽均大高科医药科技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餐后条件下的生物等效性。
[Translation] Main objective: This study used Betahistine Hydrochloride Tablets (manufacturer: Beijing Jingfeng Pharmaceutical Group Co., Ltd., specification: 8 mg) provided by Anhui Junda High-tech Pharmaceutical Technology Co., Ltd. as the test preparation, and Betahistine Hydrochloride Tablets (licensed manufacturer: Mylan Products Ltd., trade name: Serc, specification: 8 mg) provided by Anhui Junda High-tech Pharmaceutical Technology Co., Ltd. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fed conditions.
盐酸倍他司汀片(8mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, crossover bioequivalence study of betahistine hydrochloride tablets (8 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:本研究以安徽均大高科医药科技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,以安徽均大高科医药科技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。
[Translation] Main research purpose: This study used Betahistine Hydrochloride Tablets (manufacturer: Beijing Jingfeng Pharmaceutical Group Co., Ltd., specification: 8 mg) provided by Anhui Junda High-tech Pharmaceutical Technology Co., Ltd. as the test preparation, and Betahistine Hydrochloride Tablets (licensed manufacturer: Mylan Products Ltd., trade name: Serc, specification: 8 mg) provided by Anhui Junda High-tech Pharmaceutical Technology Co., Ltd. as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation under fasting and fed conditions.
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