KCT0000985已完成未知
An open-label, randomized, single-dose crossover study to compare the pharmacokinetics after the administration of HCP1201 tablet 500/10 mg and coadministration of metformin SR 500 mg and rosuvastatin 10 mg in healthy volunteers
Hanmi Pharm0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 55(Year)（—）
- 性别
- Male
入选标准
- •1) Healthy male volunteer, age 20~55 years
- •2) The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- •3) Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- •4) Subject who has the ability and willingness to participate the whole period of trial
排除标准
- •1) Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
- •2) Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
- •3) Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
- •4) SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower thatn 60mmHg or higher than 100mmHg
- •5) History of relevant drug allergies or clinically significant hypersensitivity reaction.
- •6) Subjects who judged ineligible by the investigator.
研究者
相似试验
招募中
不适用
An open-label, randomized, single-dose crossover study to compare the pharmacokinetics after the administration of HCP1201 tablet 750/20 mg and coadministration of metformin SR 750 mg and rosuvastatin 20 mg in healthy volunteersDiseases of the circulatory systemKCT0000834Hanmi Pharm72
已完成
不适用
An open-label, randomized, single-dose crossover study to evaluate the effect of food on the pharmacokinetics of HCP1201 tablet in healthy volunteersDiseases of the circulatory systemKCT0000786Hanmi Pharm12
已完成
不适用
A randomized, open-label, single-dose, crossover study to compare the safety, tolerability and pharmacokinetics of ginsenosides after oral administrations of fermented Red ginseng concentrate and Red ginseng concentrate in healthy volunteersKCT0006791Kyung Hee University Hospital16
已完成
不适用
The aim of this study is to compare and evaluate the pharmacokinetic properties and safety of oral administration of KD4002Endocrine, nutritional and metabolic diseasesKCT0007759Kyung Dong Pharmaceutical32
已完成
不适用
A randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin SR and rosuvastatin and JLP-1310 in healthy male volunteersKCT0002471Jeil Pharmaceutical40