/ CompletedNot Applicable [Translation] Bioequivalence study of ondansetron hydrochloride tablets in human body
主要研究目的:研究空腹和餐后状态下单次口服受试制剂盐酸昂丹司琼片(规格:8 mg,南京海鲸药业股份有限公司生产)与参比制剂盐酸昂丹司琼片(Zofran®,规格:8 mg,Novartis Pharma GmbH生产)在健康受试者体内的药代动力学,评价空腹和餐后状态口服两种制剂的生物等效性。
次要研究目的:评估受试制剂盐酸昂丹司琼片(规格:8 mg)和参比制剂盐酸昂丹司琼片(Zofran®,规格:8 mg)在健康受试者中的安全性。
[Translation] The main purpose of the study is to study the pharmacokinetics of the test preparation ondansetron hydrochloride tablets (specification: 8 mg, produced by Nanjing Haijing Pharmaceutical Co., Ltd.) and the reference preparation ondansetron hydrochloride tablets (Zofran®, specification: 8 mg, produced by Novartis Pharma GmbH) in healthy subjects after a single oral administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state.
Secondary purpose of the study: to evaluate the safety of the test preparation ondansetron hydrochloride tablets (specification: 8 mg) and the reference preparation ondansetron hydrochloride tablets (Zofran®, specification: 8 mg) in healthy subjects.
/ Active, not recruitingNot Applicable [Translation] Bioequivalence study of ezetimibe tablets in humans
主要目的:
在健康男性与女性受试者中于空腹/餐后条件下,评价受试制剂依折麦布片(规格:10 mg,生产商:南京海鲸药业股份有限公司)和MSD Pharma(Singapore)Pte. Ltd.为持证商的参比制剂依折麦布片(益适纯®,规格:10 mg)的生物等效性。
次要目的:
观察受试制剂依折麦布片与参比制剂依折麦布片(益适纯®)在健康受试者中的安全性。
[Translation] Primary objective:
To evaluate the bioequivalence of the test preparation Ezetimibe Tablets (Specification: 10 mg, Manufacturer: Nanjing Haijing Pharmaceutical Co., Ltd.) and the reference preparation Ezetimibe Tablets (Ezetimibe®, Specification: 10 mg) of which MSD Pharma (Singapore) Pte. Ltd. is the licensee in healthy male and female subjects under fasting/postprandial conditions.
Secondary objective:
To observe the safety of the test preparation Ezetimibe Tablets and the reference preparation Ezetimibe Tablets (Ezetimibe®) in healthy subjects.
/ CompletedNot Applicable 拉莫三嗪缓释片(50 mg)随机、开放、两周期、两交叉单次空腹/餐后状态下在健康受试者中的生物等效性试验
[Translation] A randomized, open-label, two-period, two-crossover single-dose bioequivalence study of lamotrigine extended-release tablets (50 mg) in healthy volunteers under fasting/fed conditions
主要目的:
在健康男性与女性受试者中于空腹/餐后条件下评价受试制剂和参比制剂的生物等效性。
次要目的:
观察受试制剂与参比制剂在健康受试者中的安全性。
[Translation] Primary objective:
To evaluate the bioequivalence of the test formulation and the reference formulation in healthy male and female subjects under fasting/fed conditions.
Secondary objective:
To observe the safety of the test formulation and the reference formulation in healthy subjects.
100 Clinical Results associated with Nanjing Haijing Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Nanjing Haijing Pharmaceutical Co., Ltd.
100 Deals associated with Nanjing Haijing Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Nanjing Haijing Pharmaceutical Co., Ltd.