|
|
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date05 Jul 2004 |
/ CompletedNot Applicable [Translation] Study on the bioequivalence of polyprene zinc orally disintegrating tablets in healthy volunteers
主要目的:比较空腹和餐后给药条件下受试制剂华润双鹤利民药业(济南)有限公司提供的聚普瑞锌口腔崩解片(规格:75 mg)与参比制剂ゼリア新薬工業株式会社持证的聚普瑞锌口腔崩解片(商品名:Promac® D;规格:75 mg)在中国健康人群吸收程度和吸收速度的差异,评价两制剂的生物等效性。
次要目的:
1)评价空腹及餐后条件下,受试制剂与参比制剂在中国健康参与者体内的安全性。
2)评价空腹及餐后条件下,制剂在中国健康人群中的用药口感,为聚普瑞锌口腔崩解片用药口感提供依据。
[Translation] Primary Objective: To compare the extent and rate of absorption of the test formulation, 75 mg polyprednisolone zinc orally disintegrating tablets (supplied by China Resources Double Crane Limin Pharmaceuticals (Jinan) Co., Ltd.), and the reference formulation, 75 mg polyprednisolone zinc orally disintegrating tablets (trade name: Promac® D) from Zeria Shinyaku Kogyo Co., Ltd., in healthy Chinese subjects under fasting and fed conditions, and to evaluate the bioequivalence of the two formulations.
Secondary Objectives:
1) To evaluate the safety of the test formulation and the reference formulation in healthy Chinese subjects under fasting and fed conditions.
2) To evaluate the oral texture of the formulations in healthy Chinese subjects under fasting and fed conditions, and to provide evidence for the oral texture of polyprednisolone zinc orally disintegrating tablets.
/ CompletedNot Applicable [Translation] Study on the bioequivalence of aluminum magnesium aspirin tablets (II) in healthy volunteers
主要目的:
比较空腹和餐后给药条件下华润双鹤利民药业(济南)有限公司提供的铝镁匹林片(II)(规格:每片含阿司匹林81 mg,重质碳酸镁22 mg,甘羟铝11 mg)与Lion Corporation持证的铝镁匹林片(II)(商品名:BUFFERIN Combination Tab. A81;规格:每片含阿司匹林81 mg,重质碳酸镁22 mg,甘羟铝11 mg)在中国健康人群吸收程度和吸收速度的差异。
次要目的:
评价空腹及餐后条件下,华润双鹤利民药业(济南)有限公司提供的铝镁匹林片(II)(规格:每片含阿司匹林81 mg,重质碳酸镁22 mg,甘羟铝11 mg)与Lion Corporation持证的铝镁匹林片(II)(商品名:BUFFERIN Combination Tab. A81;规格:每片含阿司匹林81 mg,重质碳酸镁22 mg,甘羟铝11 mg)在健康研究参与者体内的安全性。
[Translation] Main purpose:
To compare the differences in the degree and rate of absorption of aluminum magnesium aspirin tablets (II) (specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) provided by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. and aluminum magnesium aspirin tablets (II) (trade name: BUFFERIN Combination Tab. A81; specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) certified by Lion Corporation in healthy Chinese population under fasting and postprandial administration conditions.
Secondary objective: To evaluate the safety of BUFFERIN Combination Tab. A81 (Specification: Each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, and 11 mg aluminum glycolate) provided by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. and BUFFERIN Combination Tab. A81 (Specification: Each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, and 11 mg aluminum glycolate) certified by Lion Corporation in healthy study participants under fasting and postprandial conditions.
/ CompletedNot Applicable 硝苯地平控释片(30mg)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 nifedipine controlled-release tablets (30 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Bayer AG持证的硝苯地平控释片(商品名:拜新同®;规格:30mg)为参比制剂,对华润双鹤利民药业(济南)有限公司生产并提供的受试制剂硝苯地平控释片(规格:30mg)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:观察健康受试者口服受试制剂硝苯地平控释片(规格:30mg)和参比制剂硝苯地平控释片(商品名:拜新同®;规格:30mg)的安全性。
[Translation] Main research purpose: According to the relevant provisions of bioequivalence test, the nifedipine controlled-release tablets (trade name: Bayer AG; specification: 30 mg) certified by Bayer AG were selected as the reference preparation, and the test preparation nifedipine controlled-release tablets (specification: 30 mg) produced and provided by China Resources Double Crane Limin Pharmaceutical (Jinan) 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 research purpose: To observe the safety of oral administration of the test preparation nifedipine controlled-release tablets (specification: 30 mg) and the reference preparation nifedipine controlled-release tablets (trade name: Bayer AG; specification: 30 mg) by healthy subjects.
100 Clinical Results associated with China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.
0 Patents (Medical) associated with China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.
100 Deals associated with China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.
100 Translational Medicine associated with China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.