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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date10 Jan 2022 |
/ Active, not recruitingPhase 1 [Translation] Study on the pharmacokinetics of icariin soft capsules in Chinese healthy subjects
探索健康受试者口服淫羊藿素软胶囊后,体内药代动力学和物质平衡特点。
[Translation] To explore the pharmacokinetic and material balance characteristics of icariin soft capsules in healthy subjects after oral administration.
/ CompletedNot Applicable 健康受试者空腹及餐后状态下口服羟苯磺酸钙片后
人体生物等效性试验
[Translation] Human bioequivalence study after oral administration of calcium dobesilate tablets in healthy subjects in fasting and postprandial states
主要试验目的:在中国健康受试者中评价单次空腹和单次餐后服用宁夏康亚药业股份有限公司生产的羟苯磺酸钙片0.25 g(规格:0.25 g/片;受试制剂)和OM pharma S.A.生产的羟苯磺酸钙片250 mg(商品名:Doxium;规格:250 mg/片;参比制剂)的生物等效性;
次要试验目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Primary study objective: To evaluate the bioequivalence of single fasting and single postprandial administration of calcium dobesilate tablets 0.25 g (specification: 0.25 g/tablet; test preparation) produced by Ningxia Kangya Pharmaceutical Co., Ltd. and calcium dobesilate tablets 250 mg (trade name: Doxium; specification: 250 mg/tablet; reference preparation) produced by OM pharma S.A. in healthy Chinese subjects; Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.
/ CompletedNot Applicable 沙格列汀二甲双胍缓释片(Ⅰ)在健康人群中的生物等效性试验
[Translation] Bioequivalence study of saxagliptin and metformin extended-release tablets (Ⅰ) in healthy subjects
在健康受试者体内,分别在空腹和餐后条件下,以AstraZeneca AB持有的沙格列汀二甲双胍缓释片(Ⅰ)为参比制剂,研究北京康而福药业有限责任公司研制的沙格列汀二甲双胍缓释片(Ⅰ)的吸收速度与吸收程度,评价受试制剂与参比制剂是否具有生物等效性。观察健康受试者口服受试制剂和参比制剂的安全性。
[Translation] In healthy subjects, the absorption rate and extent of Saxagliptin Metformin Sustained-Release Tablets (I) developed by Beijing Kangerfu Pharmaceutical Co., Ltd. were studied under fasting and postprandial conditions, using Saxagliptin Metformin Sustained-Release Tablets (I) owned by AstraZeneca AB as the reference preparation, and the bioequivalence of the test preparation and the reference preparation was evaluated. The safety of the test preparation and the reference preparation when taken orally in healthy subjects was observed.
100 Clinical Results associated with Beijing Kangerfu Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Beijing Kangerfu Pharmaceutical Co., Ltd.
100 Deals associated with Beijing Kangerfu Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Beijing Kangerfu Pharmaceutical Co., Ltd.