/ CompletedNot Applicable 普瑞巴林口崩片在中国成年健康参与者中的生物等效性研究
[Translation] Bioequivalence study of pregabalin orodisintegrating tablets in healthy adult Chinese participants
主要研究目的:研究空腹/餐后状态下口服受试制剂普瑞巴林口崩片(规格:150 mg,江西施美药业股份有限公司生产)与参比制剂普瑞巴林口崩片(商品名:Lyrica;规格:150 mg,ヴィアトリス製薬株式会社生产)在中国健康成年参与者体内的药代动力学特征,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂普瑞巴林口崩片和参比制剂Lyrica在中国健康成年参与者中的安全性。
[Translation] Main study objectives: To study the pharmacokinetic characteristics of the test preparation pregabalin orodisintegrating tablets (specification: 150 mg, produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation pregabalin orodisintegrating tablets (trade name: Lyrica; specification: 150 mg, produced by Viatris Pharmaceutical Co., Ltd.) in healthy Chinese adult participants when taken orally in the fasting/fed state, and to evaluate the bioequivalence of the two preparations when taken orally in the fasting/fed state.
Secondary study objective: To evaluate the safety of the test formulation of pregabalin orally disintegrating tablets and the reference formulation of Lyrica in healthy adult participants in China.
/ CompletedNot Applicable 比索洛尔氨氯地平片在中国成年健康受试者中的生物等效性研究
[Translation] Bioequivalence study of bisoprolol and amlodipine tablets in healthy adult Chinese subjects
主要研究目的:研究空腹/餐后状态下口服受试制剂比索洛尔氨氯地平片与参比制剂康忻安在中国健康成年受试者体内的药代动力学特征,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂比索洛尔氨氯地平片和参比制剂康忻安在中国健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation bisoprolol amlodipine tablets and the reference preparation Kangxinan in healthy Chinese adult subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary purpose of the study is to evaluate the safety of the test preparation bisoprolol amlodipine tablets and the reference preparation Kangxinan in healthy Chinese adult subjects.
/ CompletedNot Applicable 依折麦布阿托伐他汀钙片在中国成年健康受试者中的生物等效性研究
[Translation] Bioequivalence study of ezetimibe and atorvastatin calcium tablets in Chinese healthy adult subjects
主要研究目的:研究空腹/餐后状态下口服受试制剂依折麦布阿托伐他汀钙片(规格:每片含依折麦布10mg与阿托伐他汀钙20mg(以阿托伐他汀计),江西施美药业股份有限公司生产)与参比制剂依折麦布阿托伐他汀钙片(商品名:Atozet;规格:每片含依折麦布10mg与阿托伐他汀钙20mg(以阿托伐他汀计),Merck Sharp & Dohme B.V.生产)在中国健康成年受试者体内的药代动力学特征,评价空腹/餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂依折麦布阿托伐他汀钙片和参比制剂依折麦布阿托伐他汀钙片(Atozet)在中国健康成年受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Ezetimibe Atorvastatin Calcium Tablets (Specifications: Each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin calcium (calculated as atorvastatin), produced by Jiangxi Shimei Pharmaceutical Co., Ltd.) and the reference preparation Ezetimibe Atorvastatin Calcium Tablets (trade name: Atozet; Specifications: Each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin calcium (calculated as atorvastatin), produced by Merck Sharp & Dohme B.V.) in healthy adult Chinese subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state.
Secondary purpose of the study: To evaluate the safety of the test preparation Ezetimibe Atorvastatin Calcium Tablets and the reference preparation Ezetimibe Atorvastatin Calcium Tablets (Atozet) in healthy adult Chinese subjects.
100 Clinical Results associated with Shandong Chuangxin Pharmaceutical Research & Development Co., Ltd.
0 Patents (Medical) associated with Shandong Chuangxin Pharmaceutical Research & Development Co., Ltd.
100 Deals associated with Shandong Chuangxin Pharmaceutical Research & Development Co., Ltd.
100 Translational Medicine associated with Shandong Chuangxin Pharmaceutical Research & Development Co., Ltd.