A Multi-center, Randomized, Double-blind, Active-controlled, Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia

A Multi-center, Randomized, double-blind, active-controlled, phase 3 trial to evaluate the safety and efficacy of Metformin/Atorvastatin in subjects with Type II Diabetes and dyslipidemia.

开始日期2015-08-01

申办/合作机构

Daewoong Pharmaceutical Co., Ltd.

NCT02378441 / Completed临床1期

A Randomized, Open-labeled, Single-dose, Crossover Design Clinical Trial to Evaluate Pharmacokinetics and Safety of CJ-30056 20/750mg and Co-administration of Lipitor® 20mg and Glucophage SR 750mg in Fed Healthy Male Subjects

This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg and metformin SR 750mg, in healthy volunteers.

开始日期2015-02-01

申办/合作机构

HK inno.N Corp.

NCT02185066 / Completed临床1期

Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor/Glucophage XR

This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin and metformin XR, in healthy volunteers.

开始日期2014-07-01

申办/合作机构

HK inno.N Corp.

100 项与阿托伐他汀钙/盐酸二甲双胍相关的临床结果

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100 项与阿托伐他汀钙/盐酸二甲双胍相关的转化医学

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100 项与阿托伐他汀钙/盐酸二甲双胍相关的专利（医药）

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项与阿托伐他汀钙/盐酸二甲双胍相关的文献（医药）

Drug Design, Development and Therapy3区 · 医学

<p>Pharmacokinetics of fixed-dose combination of atorvastatin and metformin compared with individual tablets</p>

3区 · 医学

ArticleOA

作者: Phuong, Nguyen Thi Thu ; Kim, Eun-Ji ; Kim, Eun-Young ; Ahn, Sangzin ; Shin, Jae-Gook ; Ghim, Jong-Lyul ; Song, Geun Seog ; Kim, Min Jung

Purpose: The aims of this study was to investigate the mutual pharmacokinetic interactions between steady-state atorvastatin and metformin and the effect of food on the fixed-dose combined (FDC) tablet of atorvastatin and metformin extended release (XR). Subjects and methods: Study 1, an open-labeled, fixed sequence, multiple-dose pharmacokinetic drug-drug interaction study, was divided into 2 parts. Atorvastatin (40 mg) or metformin (1,000 mg) XR tablets were administered once daily via mono- or co-therapy for 7 days. Plasma levels of atorvastatin and 2-OH-atorvastatin, were quantitatively determined for 36 h in part A (n=50) while metformin plasma concentration was measured up to 24 h in part B (n=16) after the last dosing. Study 2, a randomized, open-labeled, single-dose, two-treatment, two-period, two-sequence crossover study, involved 27 healthy subjects to investigate the impact of food intake on the pharmacokinetics of a combined atorvastatin/metformin XR 20/500 mg (CJ-30056 20/500 mg) tablet. Results: After multiple doses of mono- or co-therapy of atorvastatin (40 mg) and metformin (1,000 mg) XR, the 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) for the peak plasma concentration at steady state (C_max,ss) and area under the plasma concentration-time curve during the dosing interval at steady state (AUC_τ,ss) were 1.07 (0.94-1.22) and 1.05 (0.99-1.10) for atorvastatin, 1.06 (0.96-1.16) and 1.16 (1.10-1.21) for 2-OH-atorvastatin, and 1.00 (0.86-1.18) and 0.99 (0.87-1.13) for metformin, respectively. Food delayed time to reach maximum concentration (t_max), decreased atorvastatin C_max by 32% with a GMR (90% CI) of 0.68 (0.59-0.78), and increased metformin AUC_t by 56% with a GMR (90% CI) of 1.56 (1.43-1.69). Conclusion: No clinically relevant pharmacokinetic interaction was seen when atorvastatin was co-administered with metformin. Food appeared to change the absorption of atorvastatin and metformin from an FDC formulation. These alterations were in accordance with those described with the single reference drugs when ingested with food.

100 项与阿托伐他汀钙/盐酸二甲双胍相关的药物交易

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