A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/500 mg in Healthy Male Volunteers

This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/500 mg in healthy male volunteers.

开始日期2016-02-01

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT02648854 / Completed临床1期

A Randomized, Open-label, Single Dose, 2-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetic Characteristics of CKD-395 in Healthy Male Volunteers

This study is A randomized, open-label, single dose, 2-way crossover study to investigate the effect of food on the pharmacokinetic characteristics of CKD-395 in healthy male volunteers.

开始日期2015-10-01

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

NCT02627027 / Completed临床1期

A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/750 mg in Healthy Male Volunteers

This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.

开始日期2015-08-01

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

100 项与 Lobeglitazone Sulfate/Metformin Hydrochloride 相关的临床结果

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100 项与 Lobeglitazone Sulfate/Metformin Hydrochloride 相关的转化医学

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100 项与 Lobeglitazone Sulfate/Metformin Hydrochloride 相关的专利（医药）

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项与 Lobeglitazone Sulfate/Metformin Hydrochloride 相关的文献（医药）

2019-07-01·Clinical Pharmacology in Drug Development4区 · 医学

Pharmacokinetics of a Lobeglitazone/Metformin Fixed‐Dose Combination Tablet (CKD‐395 0.5/1000 mg) Versus Concomitant Administration of Single Agents and the Effect of Food on the Metabolism of CKD‐395 in Healthy Male Subjects

4区 · 医学

Article

作者: Kim, Sun‐Young ; Park, Shin Jung ; Jeon, Ji‐Young ; Kim, Min‐Gul

AbstractThis study aimed to compare the pharmacokinetic profile of combined CKD‐395 0.5/1000 mg treatment with that of the coadministration of lobeglitazone sulfate 0.5 mg and metformin hydrochloride (HCl) extended‐release (XR) 1000 mg and assess the effect of food on the pharmacokinetics of CKD‐395 0.5/1000 mg. Two clinical trials were conducted as part of an open‐label, single‐dose, randomized, 2‐period, 2‐sequence crossover study. In study 1, a total of 26 subjects received either CKD‐395 0.5/1000 mg as a test drug or coadministration of lobeglitazone sulfate 0.5 mg and metformin HCl XR 1000 mg individually as a reference treatment under fed conditions. In study 2, a total of 16 subjects received CKD‐395 0.5/1000 mg treatment under either fasted or fed conditions. Blood samples were collected at intervals from 0 to 48 hours. In study 1, the geometric mean ratios and 90% confidence intervals of pharmacokinetic parameters for lobeglitazone and metformin were all within 80%–125% in the fed condition. In study 2, there were no high‐fat meal effects on the area under the curve extending up to the last sampling time (AUClast) of lobeglitazone, but there was a decrease in the maximum plasma concentration (Cmax) of lobeglitazone by approximately 32% in the fed condition. Although the AUClast of metformin increased by approximately 70% in the fed condition, there was no effect of food on the Cmax of metformin, which is consistent with the already‐established food effect on metformin HCl XR. No adverse drug reactions or serious adverse events were observed. This study suggests that CKD‐395 0.5/1000 mg exhibits similar exposure and absorption rates to coadministration of single agents and is well tolerated under both fasted and fed conditions.

100 项与 Lobeglitazone Sulfate/Metformin Hydrochloride 相关的药物交易

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