[Translation] Study on human bioequivalence of pioglitazone and metformin tablets
采用单中心、随机、开放、双周期、自身交叉、单剂量给药设计,评价浙江金必康医药科技有限公司持证的吡格列酮二甲双胍片(15mg/500mg)与武田テバ薬品株式会社持证的吡格列酮二甲双胍片(15mg/500mg)在健康人群空腹、餐后口服的生物等效性,为浙江金必康医药科技有限公司持证的吡格列酮二甲双胍片与武田テバ薬品株式会社持证的吡格列酮二甲双胍片临床疗效的一致性提供证据,并评价浙江金必康医药科技有限公司持证的吡格列酮二甲双胍片(15mg/500mg)的安全性。
[Translation] A single-center, randomized, open, two-cycle, self-crossover, and single-dose design was used to evaluate the licensed pioglitazone metformin tablets (15 mg/500 mg) of Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd. and the licensed pioglitazone metformin tablets of Takeda Tube Co., Ltd. The bioequivalence of (15mg/500mg) in healthy people when taken on an empty stomach and after meals provides consistency in the clinical efficacy of pioglitazone metformin tablets certified by Zhejiang Jinbi Kang Pharmaceutical Technology Co., Ltd. and pioglitazone metformin tablets certified by Takeda Co., Ltd. Evidence, and evaluate the safety of pioglitazone metformin tablets (15mg/500mg) certified by Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd.
[Translation] Study on Bioequivalence of Pentoxifylline Sustained-release Tablets in Human Body
采用单中心、随机、开放、自身交叉、单剂量、空腹两周期及餐后四周期给药设 计,比较空腹和餐后给药条件下,浙江金必康医药科技有限公司提供的己酮可可碱缓释片(规格:400 mg)与 Aventis Pharma Limited/Sanofi 子公司 Sanofi-Aventis Deutschland GmbH 持证的己酮可可碱缓释片(400 mg;商品名: Trental®)在中国健康人群中吸收程度和吸收速度的差异,并评价浙江金必康医药科技有限公司提供的己酮可可碱缓释片(规格:400 mg)的 安全性。
[Translation] Using a single-center, randomized, open, self-crossover, single-dose, two-period fasting and four-period postprandial administration design, compare fasting and postprandial administration conditions, and the sustained-release pentoxifylline provided by Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd. Tablets (Specification: 400 mg) and Pentoxifylline Sustained Release Tablets (400 mg; trade name: Trental®) licensed by Aventis Pharma Limited/Sanofi-Aventis Deutschland GmbH, a subsidiary of Sanofi, in the extent and rate of absorption in Chinese healthy population and evaluate the safety of pentoxifylline sustained-release tablets (specification: 400 mg) provided by Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd.
评估受试制剂氨氯地平贝那普利胶囊(规格:5 mg:10 mg)与参比制剂Lotrel®(规格:5 mg:10 mg)在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、交叉生物等效性研究
[Translation] To evaluate the effect of the test preparation amlodipine benazepril capsules (specification: 5 mg:10 mg) and the reference preparation Lotrel® (specification: 5 mg:10 mg) in the fasting and postprandial state of healthy adult subjects. Central, open, randomized, single dose, crossover bioequivalence study
研究空腹和餐后状态下单次口服受试制剂氨氯地平贝那普利胶囊(规格:5 mg:10 mg,浙江金必康医药科技有限公司研制,乐普制药科技有限公司生产)与参比制剂氨氯地平贝那普利胶囊(Lotrel®,规格:5 mg:10 mg,Novartis Pharmaceuticals Corporation(美国)持证,Eon Labs Inc.生产)在健康受试者体内的药代动力学特征,评价空腹和餐后状态口服两种制剂的生物等效性。
[Translation] Study the single oral administration of the test preparation amlodipine benazepril capsules (specification: 5 mg:10 mg, developed by Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd., produced by Lepu Pharmaceutical Technology Co., Ltd.) and the reference preparation under fasting and postprandial states The pharmacokinetic characteristics of amlodipine benazepril capsules (Lotrel®, specification: 5 mg:10 mg, licensed by Novartis Pharmaceuticals Corporation (USA), produced by Eon Labs Inc.) in healthy subjects were evaluated by fasting Bioequivalence of the two preparations orally in the fed state.
100 Clinical Results associated with Zhejiang Jinbikang Pharmaceutical Technology Co., Ltd
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