氯化钾缓释片(8mEq)在健康受试者空腹人体生物等效性研究
[Translation] Bioequivalence study of potassium chloride sustained-release tablets (8 mEq) in healthy subjects on a fasting diet
主要研究目的:按有关生物等效性试验的规定,选择UPSHER-SMITH LABORATORIES INC为持证商的氯化钾缓释片(商品名:KLOR-CON®,规格:8mEq)为参比制剂,对澳美制药(海南)有限公司生产并提供的受试制剂氯化钾缓释片(规格:8mEq)进行空腹给药人体生物等效性预试验,评估两制剂的药代动力学特征,为正式试验设计提供参考依据。
次要研究目的:观察健康志愿受试者口服受试制剂氯化钾缓释片(规格:8mEq)和参比制剂氯化钾缓释片(商品名:KLOR-CON®,规格:8mEq)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, potassium chloride sustained-release tablets (trade name: KLOR-CON®, specification: 8mEq) with UPSHER-SMITH LABORATORIES INC as the licensee were selected as the reference preparation, and the test preparation potassium chloride sustained-release tablets (specification: 8mEq) produced and provided by Aome Pharmaceutical (Hainan) Co., Ltd. were used for fasting human bioequivalence preliminary test to evaluate the pharmacokinetic characteristics of the two preparations and provide reference for the formal test design.
Secondary research purpose: To observe the safety of oral administration of the test preparation potassium chloride sustained-release tablets (specification: 8mEq) and the reference preparation potassium chloride sustained-release tablets (trade name: KLOR-CON®, specification: 8mEq) by healthy volunteers.
拉考沙胺片(100mg)健康受试者空腹、餐后人体生物等效性研究
[Translation] A study on the bioequivalence of lacosamide tablets (100 mg) in healthy subjects after fasting and feeding
主要目的:本研究以澳美制药(海南)有限公司研发的拉考沙胺片(规格:100 mg)为受试制剂,按生物等效性研究的有关规定,以原研厂家Aesica Pharmaceuticals GmbH生产的拉考沙胺片(规格:100 mg,商品名:维派特®)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:观察受试制剂拉考沙胺片和参比制剂拉考沙胺片(维派特®)在健康受试者中的安全性。
次要目的:观察受试制剂富马酸卢帕他定片和参比制剂富马酸卢帕他定片(Rupafin®)在健康受试者中的安全性。
[Translation] Primary objective: This study used lacosamide tablets (specification: 100 mg) developed by Aome Pharmaceuticals (Hainan) Co., Ltd. as the test preparation. According to the relevant provisions of bioequivalence studies, lacosamide tablets (specification: 100 mg, trade name: Vipat®) produced by the original manufacturer Aesica Pharmaceuticals GmbH 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 objective: To observe the safety of the test preparation lacosamide tablets and the reference preparation lacosamide tablets (Vipat®) in healthy subjects.
Secondary objective: To observe the safety of the test preparation rupatadine fumarate tablets and the reference preparation rupatadine fumarate tablets (Rupafin®) in healthy subjects.
普瑞巴林胶囊(150mg)在健康受试者中空腹/餐后状态下的生物等效性研究
[Translation] Bioequivalence study of pregabalin capsules (150 mg) in healthy subjects under fasting and fed conditions
主要目的:
本研究以澳美制药(海南)有限公司研发的普瑞巴林胶囊(规格:150mg)为受试制剂,按生物等效性研究的有关规定,以原研厂家Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg生产,辉瑞制药有限公司分包装的普瑞巴林胶囊(规格:150mg,商品名:乐瑞卡(LYRICA))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:
观察受试制剂普瑞巴林胶囊和参比制剂普瑞巴林胶囊(乐瑞卡(LYRICA))在健康受试者中的安全性。
[Translation] Main purpose:
This study used pregabalin capsules (specification: 150 mg) developed by Aome Pharmaceuticals (Hainan) Co., Ltd. as the test preparation. According to the relevant regulations of bioequivalence studies, pregabalin capsules (specification: 150 mg, trade name: LYRICA) produced by the original manufacturer Pfizer Manufacturing Deutschland GmbH, Betriebsstatte Freiburg and packaged by Pfizer Pharmaceuticals Co., Ltd. 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:
Observe the safety of the test preparation pregabalin capsules and the reference preparation pregabalin capsules (LYRICA) in healthy subjects.
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