[Translation] Study on the bioequivalence of toremifene citrate tablets in healthy volunteers
主要目的:
本研究以重庆士立德医药科技有限公司研发的枸橼酸托瑞米芬片(规格:60 mg)为受试制剂,按生物等效性研究的有关规定,以原研厂家Orion Corporation生产的枸橼酸托瑞米芬片(规格:60 mg,商品名:法乐通®)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
次要目的:
观察受试制剂枸橼酸托瑞米芬片和参比制剂枸橼酸托瑞米芬片(法乐通®)在健康受试者中的安全性。
[Translation] Main purpose:
This study used toremifene citrate tablets (specification: 60 mg) developed by Chongqing Shilide Pharmaceutical Technology Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, toremifene citrate tablets (specification: 60 mg, trade name: Faleton®) produced by the original manufacturer Orion Corporation were used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary purpose:
To observe the safety of the test preparation toremifene citrate tablets and the reference preparation toremifene citrate tablets (Faleton®) in healthy subjects.
[Translation] Study on the bioequivalence of baclofen tablets in healthy volunteers
主要目的:
本研究以重庆士立德医药科技有限公司持有的巴氯芬片(规格:10 mg)为受试制剂,按生物等效性研究的有关规定,以原研厂家Novartis Farma S.p.A,生产的巴氯芬片(规格:10 mg,商品名:力奥来素®/Lioresal®)为参比制剂,评估受试制剂和参比制剂在空腹/餐后条件下给药后的生物等效性。
次要目的:
观察受试制剂巴氯芬片和参比制剂巴氯芬片(力奥来素®/Lioresal®)在健康受试者中的安全性。
[Translation] Main purpose:
This study uses baclofen tablets (specification: 10 mg) owned by Chongqing Shilide Pharmaceutical Technology Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, baclofen tablets (specification: 10 mg, trade name: Lioresal®/Lioresal®) produced by the original manufacturer Novartis Farma S.p.A. are used as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation after administration under fasting/postprandial conditions.
Secondary purpose:
Observe the safety of the test preparation baclofen tablets and the reference preparation baclofen tablets (Lioresal®/Lioresal®) in healthy subjects.
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