NCT03175835已完成1 期
An Open-label, Multiple Dose, Fixed-sequence, 3-period Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (Area under the plasma concentration versus time curve (AUCτ))
研究概览
简要总结
The purpose of this study is to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.
详细描述
An open-label, multiple dose, fixed-sequence, 3-period study to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged between ≥ 20 and ≤ 45 years old
- •Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
- •Subjects to consents to use effective birth controls for at least 2 months following the last dose
- •Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written
排除标准
- •History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder
- •With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
- •Any medical history that may affect drug absorption, distribution, metabolism and excretion
- •Any hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of statin-related medication or Cholesteryl Ester Transfer Protein(CETP) inhibitor or other drugs(aspirin, antibiotics)
- •Continuous cryptogenic elevation of serum transaminase or active liver disease including elevation of serum transaminase > 3 fold upper normal limit(UNL)
- •Severe renal failure(creatinin clearance < 30 ml/min)
- •Hypothyroidism or clinically significant test result
- •Galactose intolerance, Lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders
- •Any clinically significant chronic medical illness
- •Any clinically significant hypotension or hypertension (systolic < 100 mmHg/diastolic < 60 mmHg or systolic > 140 mmHg /diastolic > 90 mmHg)
- •Corrected QT interval(QTc) >450msec on 12-lead ECG
- •Positive blood tests for hemoglobins(HBs) Ag, anti-hepatitis C virus(HCV) Ab, anti-HIV Ab, or venereal disease research laboratory(VDRL)
- •Creatine phosphokinase(CPK) ≥ 5 fold of upper normal limit(UNL)
- •Use of any prescription drugs within 14 days prior to study drug administration
- •Use of any other drugs, including over-the-counter medications and herbal preparations within 7 days prior to study drug administration
- •History of clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not require any treatment may be allowed)
- •Inability to take normal hospital diet
- •Donation of blood within 60 days prior to study drug administration or plasma to a blood bank within 20 days prior to study drug administration
- •Blood transfusion within 30 days prior to study drug administration
- •Exposure to any investigational drug or placebo within 90 days prior to the first Investigational Product(IP) administration
- •Subjects taking any drugs to induce or inhibit drug metabolizing enzymes including barbiturates within 30 days prior to the first Investigational Product(IP) administration
- •Subjects with excessive caffeine intake (more than 5 cups/day), heavy smoking (more than 10 cigarettes/day), regular alcohol intake (more than 210 g/week)
- •Subjects having been deemed inappropriate for the trial as determined by the investigator
研究组 & 干预措施
Rosuvastatin 20 mg & CKD-519 200 mg
Experimental
Period 1: Treatment A(Rosuvastatin 20 mg(20 mg X 1 tablet))
Period 2: Treatment B(CKD-519 200 mg(100 mg X 2 tablets))
Period 3: Treatment C(Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets))
干预措施: Rosuvastatin 20 mg (Drug)
Rosuvastatin 20 mg & CKD-519 200 mg
Experimental
Period 1: Treatment A(Rosuvastatin 20 mg(20 mg X 1 tablet))
Period 2: Treatment B(CKD-519 200 mg(100 mg X 2 tablets))
Period 3: Treatment C(Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets))
干预措施: CKD-519 200 mg (Drug)
Rosuvastatin 20 mg & CKD-519 200 mg
Experimental
Period 1: Treatment A(Rosuvastatin 20 mg(20 mg X 1 tablet))
Period 2: Treatment B(CKD-519 200 mg(100 mg X 2 tablets))
Period 3: Treatment C(Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets))
干预措施: Rosuvastatin 20 mg & CKD-519 200 mg (Drug)
结局指标
主要结局
Pharmacokinetics (Area under the plasma concentration versus time curve (AUCτ))
时间窗: 0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26
At steady state after multiple administration of CKD-519, Rosuvastatin
次要结局
- Pharmacokinetics (Peak plasma Concentration (Cmax,ss))(0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26)
- Pharmacokinetics (Minimum plasma Concentration (Cmin,ss))(0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26)
- Pharmacokinetics (Time to maximum plasma concentration (Tmax,ss))(0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26)
- Pharmacokinetics (t1/2)(0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26)
- Pharmacodynamics (CETP activity)(0(predose)~24 hours at Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26)
- Pharmacodynamics (CETP Concentration)(0(predose)~24 hours at Day9, Day19, Day22, Day26)
- Pharmacodynamics (Lipid profiles)(simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27)
研究者
研究点 (1)
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