氨氯地平阿托伐他汀钙片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、三序列、三周期、部分重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, three-sequence, three-period, partially repeated crossover bioequivalence study of amlodipine and atorvastatin calcium tablets in Chinese healthy volunteers under fasting and fed conditions
按有关生物等效性试验的规定，选择Pharmacia and Upjohn Co LLC为持证商的氨氯地平阿托伐他汀钙片（商品名：Caduet®，规格：5mg/10mg（以氨氯地平/阿托伐他汀计））为参比制剂，对翎耀生物科技（上海）有限公司提供的受试制剂氨氯地平阿托伐他汀钙片（规格：5mg/10mg（以氨氯地平/阿托伐他汀计））进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在空腹和餐后给药条件下的生物等效性。
[Translation] In accordance with the relevant provisions of bioequivalence tests, amlodipine atorvastatin calcium tablets (trade name: Caduet®, specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) with Pharmacia and Upjohn Co LLC as the licensee were selected as the reference preparation, and the test preparation amlodipine atorvastatin calcium tablets (specification: 5mg/10mg (calculated as amlodipine/atorvastatin)) provided by Lingyao Biotechnology (Shanghai) Co., Ltd. were subjected to human bioequivalence tests on fasting and fed administration to compare whether the absorption rate and degree of the drug in the test preparation were within an acceptable range with those of the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and fed administration conditions.
依折麦布片（10mg）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、四周期、完全重复交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of ezetimibe tablets (10 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的：按有关生物等效性试验的规定，选择MSD PHARMA (Singapore) Pte. Ltd.为持证商的依折麦布片（商品名：Ezetrol（益适纯），规格：10mg）为参比制剂，对江苏复旦复华药业有限公司生产，翎耀生物科技（上海）有限公司提供的受试制剂依折麦布片（规格：10mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的：观察健康志愿受试者口服受试制剂依折麦布片（规格：10mg）和参比制剂依折麦布片（商品名：Ezetrol（益适纯），规格：10mg）的安全性。
[Translation] Main purpose of study: According to the relevant provisions of bioequivalence test, Ezetrol Tablets (trade name: Ezetrol, specification: 10mg) of MSD PHARMA (Singapore) Pte. Ltd. as the licensee was selected as the reference preparation, and the test preparation Ezetrol Tablets (specification: 10mg) produced by Jiangsu Fudan Fuhua Pharmaceutical Co., Ltd. and provided by Lingyao Biotechnology (Shanghai) Co., Ltd. were subjected to human bioequivalence test on fasting and postprandial administration, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary purpose of study: To observe the safety of oral administration of the test preparation Ezetrol Tablets (specification: 10mg) and the reference preparation Ezetrol Tablets (trade name: Ezetrol, specification: 10mg) by healthy volunteers.
瑞舒伐他汀钙片（10mg）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、双交叉生物等效性试验。
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of rosuvastatin calcium tablets (10 mg) in Chinese healthy subjects under fasting and fed dosing conditions.
主要研究目的：按有关生物等效性试验的规定，选择Astrazeneca UK Limited持证，IPR Pharrmaceuticals，INCORPORATED生产的瑞舒伐他汀钙片（商品名：Crestor®，规格：10mg）为参比制剂，对翎耀生物科技（上海）有限公司提供的受试制剂瑞舒伐他汀钙片（规格：10mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的：观察健康志愿受试者口服受试制剂瑞舒伐他汀钙片（规格：10mg）和参比制剂瑞舒伐他汀钙片（商品名：Crestor®，规格：10mg）的安全性。
[Translation] Main purpose of study: According to the relevant provisions of bioequivalence test, rosuvastatin calcium tablets (trade name: Crestor®, specification: 10 mg) produced by Astrazeneca UK Limited and IPR Pharrmaceuticals, INCORPORATED were selected as the reference preparation, and the test preparation rosuvastatin calcium tablets (specification: 10 mg) provided by Lingyao Biotechnology (Shanghai) Co., Ltd. were subjected to fasting and postprandial human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions.
Secondary purpose of study: To observe the safety of oral administration of the test preparation rosuvastatin calcium tablets (specification: 10 mg) and the reference preparation rosuvastatin calcium tablets (trade name: Crestor®, specification: 10 mg) by healthy volunteers.
100 Clinical Results associated with Lingyao Biotechnology (Shanghai) Co., Ltd.
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