NCT07404735已完成1 期
A Randomized, Open-label and Parallel Study to Evaluate the Pharmacokinetics and Safety of CKD-846 in Healthy Male Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Plasma Concentration of D091
研究概览
简要总结
A Clinical trial to compare and evaluate evaluate the pharmacokinetics and safety of CKD-846
详细描述
A randomized, open-label and parallel study to evaluate the pharmacokinetics and safety of CKD-846 in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy man aged between 19 to 55 at screening
- •Weight ≥ 55kg
- •Body mass index (BMI) of 18.5 to 27.0kg/m2
- •Those who agree to contraception from the first Investigational Product(IP) dosing day till 6 months after the last dosing day and decide not to provide sperm during the participation of clinical trial
- •Those who voluntarily decide to participate in paper and agree to comply with the cautions after fully understand the detailed description of this clinical trial
排除标准
- •Those who have clinically significant disease or medical history of Hepatopathy, Renal, Neurological, Immunity, Respiratory, Endocrine, urinary, tumor or Psychical disorder
- •Those who have a history of clinically significant cardiovascular diseases such as myocardial infarction, angina pectoris, ventricular arrhythmia, heart failure, left ventricular outflow tract stenosis, stroke, and transient ischemic attack within 2 years prior to the first administration of the investigational drug
- •Those with eye diseases including genetic degenerative retinal diseases, including retinitis pigmentosa
- •Those with a past history of erection lasting more than 4 hours and priapism while taking PDE5 inhibitors such as tadalafil
- •Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery which can interfere with drug absorption
- •Persons with a history of clinically significant hypersensitivity to drugs or additives, including ingredients of clinical investigational drugs
- •Those who have genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •A person who is judged to be unsuitable as a test subject in a screening test conducted within 28 days before administration of the investigational drug
- •Those who has a drug abuse history within one year or positive reaction on urine drug screening test.
- •Those who has taken over-the-counter or prescription drugs, excluding topical agents without significant systemic absorption, within a specified period of time and the administered drug is judged to have an effect on this test or may affect the safety of the subject
- •People who need to take nitrate preparations or nitric oxide donors etc. regularly or intermittently during the clinical trial period
- •Those who continuously smoke excessively or consume caffeine or alcohol
- •A person who consumed food containing grapefruit within 7 days before the first administration of the investigational drug
- •Persons who participated in another clinical trial (including bioequivalence test) and received an investigational drug within 180days prior to the date of first administration of the investigational drug
- •Those who donated whole blood within 60 days before the first date of administration and donated ingredients within 30 days
- •Those who have received blood transfusion in 30 days
- •Those who are deemed insufficient to participate in clinical study by investigators
研究组 & 干预措施
R (Reference group)
Experimental
D091, Multi dose
干预措施: D091 (Drug)
A3 (Test group)
Experimental
CKD-846, Single dose
干预措施: CKD-846 (Drug)
A1 (Test group)
Experimental
CKD-846, Single dose
干预措施: CKD-846 (Drug)
A2 (Test group)
Experimental
CKD-846, Single dose
干预措施: CKD-846 (Drug)
结局指标
主要结局
Plasma Concentration of D091
时间窗: Pre-dose, Post-dose Day1~Day34 (During the administration period)
Concentration of During the administration period
Plasma Concentration of CKD-846
时间窗: Pre-dose, Post-dose Day1~Day91 (During the administration period)
Concentration of During the administration period
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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