/ CompletedNot Applicable 格列齐特缓释片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的
生物等效性试验
[Translation] A randomized, open, single-dose, two-formulation, two-sequence, two-cycle crossover bioequivalence study of gliclazide sustained-release tablets in healthy subjects under fasting/postprandial conditions
主要目的:健康受试者空腹/餐后状态下,口服单剂量格列齐特缓释片(受试制剂T,山东司邦得制药有限公司生产,商品名:普美康®,规格:30mg)与格列齐特缓释片(参比制剂R,施维雅(天津)制药有限公司生产,商品名:达美康®,规格:30mg)后,考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要目的:观察受试制剂格列齐特缓释片(普美康®)和参比制剂格列齐特缓释片(达美康®)在健康受试者中的安全性。
[Translation] Primary objective: To investigate the absorption rate and extent of the test preparation and the reference preparation under fasting and postprandial conditions after oral administration of a single dose of gliclazide sustained-release tablets (test preparation T, produced by Shandong Sibonde Pharmaceutical Co., Ltd., trade name: Pumeikang®, specification: 30 mg) and gliclazide sustained-release tablets (reference preparation R, produced by Servier (Tianjin) Pharmaceutical Co., Ltd., trade name: Dameikang®, specification: 30 mg) to healthy subjects, and to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary objective: To observe the safety of the test preparation gliclazide sustained-release tablets (Pumekang®) and the reference preparation gliclazide sustained-release tablets (Damekang®) in healthy subjects.
/ CompletedNot Applicable 盐酸二甲双胍缓释片在健康受试者中随机、开放、单剂量、两制剂、两序列、两周期交叉空腹/餐后状态下的生物等效性试验。
[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of metformin hydrochloride extended-release tablets in healthy subjects under fasting/fed conditions.
主要研究目的
健康受试者空腹/餐后状态下,口服单剂量盐酸二甲双胍缓释片(受试制剂T,山东司邦得制药有限公司生产,商品名:圣邦杰,规格:0.5g/片)与盐酸二甲双胍缓释片(参比制剂R,Merck KGaA生产,默克制药(江苏)有限公司进行分包装,商品名:GLUCOPHAGE XR®,规格:0.5g/片)后,考察空腹和餐后条件下受试制剂与参比制剂的吸收速度和吸收程度,评价受试制剂与参比制剂是否具有生物等效性。
次要研究目的
观察受试空腹/餐后状态下,口服单剂量观察受试制剂盐酸二甲双胍缓释片(圣邦杰®)和参比制剂盐酸二甲双胍缓释片(GLUCOPHAGE XR®)在健康受试者中的安全性。
[Translation] Main study objectives
After oral administration of a single dose of metformin hydrochloride extended-release tablets (test preparation T, produced by Shandong Sibonde Pharmaceutical Co., Ltd., trade name: Sanbond, specification: 0.5g/tablet) and metformin hydrochloride extended-release tablets (reference preparation R, produced by Merck KGaA, packaged by Merck Pharmaceuticals (Jiangsu) Co., Ltd., trade name: GLUCOPHAGE XR®, specification: 0.5g/tablet) to healthy subjects in the fasting/postprandial state, the absorption rate and degree of the test preparation and the reference preparation under fasting and postprandial conditions were investigated to evaluate whether the test preparation and the reference preparation are bioequivalent.
Secondary study objectives
Observe the safety of the test preparation metformin hydrochloride extended-release tablets (Sanbond®) and the reference preparation metformin hydrochloride extended-release tablets (GLUCOPHAGE XR®) in healthy subjects after oral administration of a single dose in the fasting/postprandial state.
/ CompletedNot Applicable 奥美拉唑碳酸氢钠胶囊随机、开放、单次给药、两制剂、两周期、交叉人体生物等效性试验
[Translation] A randomized, open, single-dose, two-formulation, two-cycle, crossover bioequivalence study of omeprazole sodium bicarbonate capsules in humans
主要研究目的:评估北京百奥药业有限责任公司生产的奥美拉唑碳酸氢钠胶囊(规格:奥美拉唑40mg/碳酸氢钠1100mg)与SALIX PHARMACEUTICALS生产的奥美拉唑碳酸氢钠胶囊(商品名:ZEGERID®,规格:奥美拉唑40mg/碳酸氢钠1100mg)在健康受试者中空腹状态下的生物等效性。 次要研究目的:观察受试制剂和参比制剂奥美拉唑碳酸氢钠胶囊在健康受试者中的安全性。
[Translation] The main purpose of the study was to evaluate the bioequivalence of omeprazole sodium bicarbonate capsules (specifications: omeprazole 40 mg/sodium bicarbonate 1100 mg) produced by Beijing Biopharma Co., Ltd. and omeprazole sodium bicarbonate capsules (trade name: ZEGERID®, specifications: omeprazole 40 mg/sodium bicarbonate 1100 mg) produced by SALIX PHARMACEUTICALS in healthy subjects under fasting conditions. The secondary purpose of the study was to observe the safety of the test preparation and the reference preparation omeprazole sodium bicarbonate capsules in healthy subjects.
100 Clinical Results associated with Shandong Sipond Pharmaceutical Co., Ltd.
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100 Deals associated with Shandong Sipond Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shandong Sipond Pharmaceutical Co., Ltd.