/ CompletedNot Applicable 盐酸沙格雷酯片在空腹和餐后条件下的人体生物等效性试验
[Translation] Human bioequivalence studies of sarpogrelate hydrochloride tablets under fasting and postprandial conditions.
考察健康试验参与者在空腹和餐后条件下,单次口服1片由远大医药(天津)有限公司提供的盐酸沙格雷酯片(受试制剂T,规格:100mg)或由Mitsubishi Tanabe Pharma Corporation持证的盐酸沙格雷酯片(参比制剂R,商品名:ANPLAG®,规格:100mg)的药动学特征,评价两制剂间的生物等效性和安全性。
[Translation] The pharmacokinetic characteristics of a single oral dose of sarpogrelate hydrochloride tablet (test formulation T, strength: 100 mg) provided by Grand Pharmaceutical (Tianjin) Co., Ltd., or sarpogrelate hydrochloride tablet (reference formulation R, trade name: ANPLAG®, strength: 100 mg) certified by Mitsubishi Tanabe Pharma Corporation, were investigated in healthy trial participants under fasting and postprandial conditions to evaluate the bioequivalence and safety between the two formulations.
100 Clinical Results associated with Tianjin Tanabe Seiyaku Co., Ltd.
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Mitsubishi Tanabe Pharma said on December 21 that it is transferring an equity stake of over 75% in its Chinese joint venture subsidiary Tianjin Tanabe to Grand Pharma (China) for 7,364 million yen. Since its inception in 1993, Tianjin Tanabe…
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