NCT07322991已完成1 期
A Phase 1 Clinical Trial With an Open-label, Single-agent Repeated Dosing Followed by Combined Repeated Dosing Design to Evaluate the Drug-drug Interaction Between IY001 and IY002 in Healthy Adult Male Subjects.
Il-Yang Pharm. Co., Ltd.1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2025年10月14日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Finasteride Area Under the Curve during the dosing interval at steady state (AUCτ,ss)
研究概览
简要总结
The purpose of this stud is to evaluate the drug-drug interaction between IY001 and IY002 in adult males.
详细描述
The study is an Open-label, Phase I, drug-drug interaction study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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 adult males aged between 19 and 55 years at screening.
- •Body weight ≥ 50 kg and body mass index (BMI) between 18 and 30 kg/m² (BMI calculated as weight [kg] / height [m]²).
- •No clinically significant congenital or chronic diseases, and no pathological signs or symptoms based on internal medicine examination (including EEG, ECG, chest or upper gastrointestinal endoscopy, or gastrointestinal radiographic examination, if necessary).
- •Considered suitable for participation by the principal investigator (or delegated sub-investigator) based on diagnostic tests such as hematology, blood chemistry, serology, urinalysis, ECG, suicide risk assessment, and depression scale evaluation conducted in accordance with the characteristics of the investigational drugs.
- •Able to provide written informed consent after receiving a detailed explanation of the clinical trial and voluntarily agreeing to participate and comply with study requirements during the trial period.
- •Agree to use highly effective contraception* (excluding hormonal methods) and refrain from donating sperm from the first dose until at least 4 weeks after the last dose of the investigational drugs. This includes agreement that the subject or their partner will avoid pregnancy.
- •*Highly effective contraception methods include: intrauterine device (IUD), bilateral tubal ligation, vasectomy of partner, or sexual abstinence. Methods such as periodic abstinence (calendar method, basal body temperature, ovulation method), withdrawal, use of spermicides alone, lactational amenorrhea, or simultaneous use of male and female condoms are not considered effective contraception.
- •Agree not to donate blood from the first dose until at least 4 weeks after the last dose of the investigational drugs.
排除标准
- •Use of drug-metabolizing enzyme inducers or inhibitors (e.g., barbiturates) within 30 days prior to the first dose, or use of such medications within 10 days prior to the first dose.
- •Participation in a bioequivalence study or other clinical trial involving investigational drugs within 6 months prior to the first dose.
- •Whole blood donation within 8 weeks, plasma donation within 2 weeks, or blood transfusion within 4 weeks prior to the first dose.
- •History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia surgery).
- •Within 1 month prior to the first dose:
- •Average alcohol consumption exceeding 21 drinks per week (1 drink = 50 mL soju, 250 mL beer, or 30 mL spirits)
- •Smoking more than 20 cigarettes per day
- •Any of the following conditions:
- •History of hypersensitivity (including angioedema) to the investigational drug or its components
- •Orthostatic hypotension
- •Severe hepatic impairment
- •Severe renal impairment
- •Currently taking PDE5 inhibitors
- •Currently taking CYP3A4 inhibitors
- •Currently taking antihypertensive drugs
- •Currently taking alpha-1 blockers
- •History of micturition syncope
- •Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Hypersensitivity or allergy to Sunset Yellow FCF (Yellow No. 5) contained in the drug
- •History of clinically significant psychiatric disorders.
- •Any other condition that the principal investigator (or delegated sub-investigator) deems makes the subject unsuitable for participation in this clinical trial.
研究组 & 干预措施
Part A
Experimental
IY001 -> IY001 + IY002
干预措施: IY001(Finasteride) (Drug)
Part A
Experimental
IY001 -> IY001 + IY002
干预措施: IY002(Tamsulosin) (Drug)
Part B
Experimental
IY002 -> IY001 + IY002
干预措施: IY001(Finasteride) (Drug)
Part B
Experimental
IY002 -> IY001 + IY002
干预措施: IY002(Tamsulosin) (Drug)
结局指标
主要结局
Finasteride Area Under the Curve during the dosing interval at steady state (AUCτ,ss)
时间窗: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)
The total drug exposure of finasteride over the dosing interval at steady state.
Finasteride Maximum Plasma Concentration at steady state (Cmax,ss)
时间窗: Measured at steady state after repeated dosing.(Day 8 compared to Day 3)
The peak plasma concentration of finasteride observed at steady state.
Tamsulosin Area Under the Curve during the dosing interval at steady state (AUCτ,ss)
时间窗: Measured at steady state after repeated dosing.(Day 8 compared to Day 5)
The total drug exposure of tamsulosin over the dosing interval at steady state.
Tamsulosin Maximum Plasma Concentration at steady state (Cmax,ss)
时间窗: Measured at steady state after repeated dosing.(Day 8 compared to Day 5)
The peak plasma concentration of tamsulosin observed at steady state.
次要结局
- Finasteride Time to Maximum Plasma Concentration at steady state (Tmax,ss)(Days 3 and 8)
- Finasteride Elimination Half-Life at Steady State (t1/2,ss)(Days 3 and 8)
- Finasteride Apparent Clearance at Steady State (CLss/F)(Days 3 and 8)
- Finasteride Minimum Plasma Concentration at Steady State (Cmin,ss)(Days 1, 2, 7, and 8)
- Finasteride Average Plasma Concentration at Steady State (Cav,ss)(Days 3 and 8)
- Finasteride Accumulation Ratio (R)(Days 3 and 8)
- Finasteride Peak-Trough Fluctuation (PTF)(Days 3 and 8)
- Tamsulosin Time to Maximum Plasma Concentration at Steady State (Tmax,ss)(Days 5 and 8)
- Tamsulosin Elimination Half-Life at Steady State (t1/2,ss)(Days 5 and 8)
- Tamsulosin Peak-Trough Fluctuation (PTF)(Days 5 and 8)
- Tamsulosin Apparent Clearance at Steady State (CLss/F)(Days 5 and 8)
- Tamsulosin Minimum Plasma Concentration at Steady State (Cmin,ss)(Days 1, 4, 7, and 8)
- Tamsulosin Average Plasma Concentration at Steady State (Cav,ss)(Days 5 and 8)
- Tamsulosin Accumulation Ratio (R)(Days 5 and 8)
研究者
研究点 (1)
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