NCT05737082已完成1 期
A Randomized, Open Label, Single Dose, 4-period Replicate Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2201 and Co-administration of RLD2205 and RLD2206 in Healthy Male Volunteers Under Fasting Conditions
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年3月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Abiraterone acetate AUCt
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2201 and co-administration of each component in fasting condition in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Age 19~55 years in healthy male volunteers
- •19 kg/m^2 ≤ BMI < 28 kg/m^2, weight ≥55kg
- •90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
- •Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
- •Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial
排除标准
- •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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Sequence 1
Experimental
- Period 1, Period 3: RLD2205 + RLD2206
- Period 2, Period 4: HCP2201
干预措施: RLD2206 (Drug)
Sequence 1
Experimental
- Period 1, Period 3: RLD2205 + RLD2206
- Period 2, Period 4: HCP2201
干预措施: HCP2201 (Drug)
Sequence 1
Experimental
- Period 1, Period 3: RLD2205 + RLD2206
- Period 2, Period 4: HCP2201
干预措施: RLD2205 (Drug)
Sequence 2
Experimental
- Period 1, Period 3: HCP2201
- Period 2, Period 4: RLD2205 + RLD2206
干预措施: HCP2201 (Drug)
Sequence 2
Experimental
- Period 1, Period 3: HCP2201
- Period 2, Period 4: RLD2205 + RLD2206
干预措施: RLD2205 (Drug)
Sequence 2
Experimental
- Period 1, Period 3: HCP2201
- Period 2, Period 4: RLD2205 + RLD2206
干预措施: RLD2206 (Drug)
结局指标
主要结局
Abiraterone acetate AUCt
时间窗: 0~72 hours
Pharmacokinetic evaluation
Abiraterone acetate Cmax
时间窗: 0~72 hours
Pharmacokinetic evaluation
Prednisolone AUCt
时间窗: 0~24 hours
Pharmacokinetic evaluation
Prednisolone Cmax
时间窗: 0~24 hours
Pharmacokinetic evaluation
次要结局
- Tmax(0~72 hours)
- t1/2(0~72 hours)
- CL/F(0~72 hours)
- Vd/F(0~72 hours)
- AUCinf(0~72 hours)
研究者
研究点 (1)
Loading locations...
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