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临床试验/NCT04185090
NCT04185090Unknown1 期

An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period Phase 1 Study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety Between ID1801 and ID1803 in Healthy Male Subjects

IlDong Pharmaceutical Co Ltd0 个研究点目标入组 30 人开始时间: 2020年2月最近更新:
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适应症

试验速览

阶段
1 期
入组人数
30
主要终点
AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe)
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is designated to evaluate the pharmacokinetic interactions of valsartan, amlodipine besylate, rosuvastatin, and ezetimibe in healthy male volunteers.

详细描述

An Open-label, Single or Multiple-dose, Fixed-sequence, 3-treatment, 3-Period phase 1 study to Evaluate the Pharmacokinetic/Pharmacodynamic Interactions and Safety between ID1801 and ID1803 in Healthy Male Subjects

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 45 Years（Adult）
性别
Male
接受健康志愿者
是

入选标准

  • •Healthy adult male volunteers aged 19 to 45 years
  • •Subjects who have over 50kg and BMI more than 18.5kg/m2 and less than 29.9kg/m2
  • •Males must be agree to practice a medically acceptable method* of birth control and will not donate sperm during the study.
  • •Subjects who provided written informed consent to participate in this study and voluntarily taken part in during the entire study period

排除标准

  • •Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
  • •Subject with symptoms of acute disease within 28days prior to study medication dosing
  • •Medical history or evidence that can affect absorption, distribution, metabolism and excretion of a given drug
  • •Drugs or other drugs (aspirin, antibiotics, etc.) that contain the following drug categories or components of the same strain have an overactive or clinically significant history of hypersensitivity:
  • •Subject with a history of drug abuse or urinalysis positive
  • •Subject with clinically significant active chronic disease
  • •Subject with genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
  • •Genetic myopathic disorder or related family history
  • •Positive test results for HBs Ab, HCV Ab, Anti HIV(AIDS), RPR Ab
  • •Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
  • •Subject who cannot take standard meal in hospitalization
  • •Present history of hypothyroidism or clinically significant assay
  • •Subjects who donated whole blood or partial blood within 2 or 1 month, respectively, prior to the first administration.
  • •Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
  • •Smokers whose average daily smoking amount exceeds 10 cigarettes per day within 3 months before the first dosing day and those who can't quit from 48 hours before dosing to the time of the last blood sampling.
  • •Subjects who judged ineligible by the investigator

结局指标

主要结局

AUCτ(Amlodipine, valsartan, rosuvastatin, free ezetimibe)

时间窗: 0~72hours

Amlodipine, valsartan, rosuvastatin, free ezetimibe: AUCτ

Cmax,ss(Amlodipine, valsartan, rosuvastatin, free ezetimibe)

时间窗: 0~72hours

Amlodipine, valsartan, rosuvastatin, free ezetimibe: Cmax,ss

次要结局

  • Cmax,ss(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss(0~72hours)
  • CLss/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)(0~72hours)
  • Tmax,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)(0~72hours)
  • Vd/F(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)(0~72hours)
  • AUCτ(N-desmethyl rosuvastatin, total ezetimibe) desmethyl rosuvastatin, total ezetimibe: AUCτ, Cmax,ss(0~72hours)
  • Cmin,ss(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)(0~72hours)
  • t1/2(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)(0~72hours)
  • PTF(amlodipine, valsartan, rosuvastatin, N-desmethyl rosuvastatin, free ezetimibe and, total ezetimibe)(0~72hours)

研究者

申办方类型
Industry
责任方
Sponsor

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