/ CompletedNot Applicable 缬沙坦氨氯地平片(I)在健康人体空腹/餐后状态下的生物等效性试验
[Translation] Bioequivalence study of valsartan amlodipine tablets (I) in healthy subjects under fasting/postprandial conditions
主要目的:本研究以山东司邦得制药有限公司持证的缬沙坦氨氯地平片(I)(规格:每片含缬沙坦80mg,氨氯地平5mg)为受试制剂,Novartis Pharma Schweiz AG持证的缬沙坦氨氯地平片(I)(商品名:倍博特®,规格:每片含缬沙坦80mg,氨氯地平5mg)为参比制剂,进行空腹/餐后状态下人体生物等效性试验,评价受试制剂和参比制剂在健康参与者体内的生物等效性。
次要目的:观察受试制剂和参比制剂在健康参与者中的安全性。
[Translation] Primary Objective: This study used valsartan-amlodipine tablets (I) (80 mg valsartan and 5 mg amlodipine per tablet), certified by Shandong Sibangde Pharmaceutical Co., Ltd., as the test formulation, and valsartan-amlodipine tablets (I) (brand name: Bebopter®, 80 mg valsartan and 5 mg amlodipine per tablet), certified by Novartis Pharma Schweiz AG, as the reference formulation, to conduct a human bioequivalence study under fasting and postprandial conditions to evaluate the bioequivalence of the test and reference formulations in healthy participants.
Secondary Objective: To observe the safety of the test and reference formulations in healthy participants.
/ 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.
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.