A Dose Block-randomized, Double-blind, Placebo Controlled, Multiple Dosing, Dose-escalation Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of DWP10292 and Ursodeoxycholic Acid in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 主要终点
- Composite of Pharmacokinetics
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.
详细描述
This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose escalation clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of DWP 10292 after oral administration 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
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints
- •Healthy adult male subjects aged 19 to 45 years
- •The subject has a Body weight ≥ 60 kg and < 90 kg and Body Mass Index(BMI) ≥ 18.5 kg/m2 and < 27.0 kg/m2
- •A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
排除标准
- •A subject with sign or symptoms or previously diagnosed disease of liver (viral hepatitis), digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant diseases and history or suspicion of current drug abuse and alcohol abuse
- •A subject who shows vital signs with the number of systolic blood pressure of ≥140 mmHg or ≤100 mmHg, and the number of diastolic blood pressure of ≥90mmHg or ≤60mmHg
- •A subject who donates his blood (whole blood donation within last 2 months or plasma donation within last 1 month) or received a blood transfusion within last 1 month
- •Subject who has taken other clinical or licensed medication from another clinical trial within an 3-month period prior to the first administration of the study medication (The last administration of the medication is considered as an end point of the previous clinical trial)
- •Subject who smokes an average of 10 cigarettes/day and is unable to quit smoking during the clinical trial
研究组 & 干预措施
DWP10292
Drug: DWP10292 DWP10292 tablets, oral administration, multiple administration
Arms: DWP10292
干预措施: DWP10292 (Drug)
DWP10292 Placebo
Drug: Placebo Placebo tablets, oral administration, multiple administrations
Arms: Placebo
干预措施: DWP10292 Placebo (Drug)
Ursodeoxycholic acid (UDCA)
Drug: Ursodeoxycholic acid (UDCA) UDCA tablets, oral administration, multiple administrations
Arms: Ursodeoxycholic acid (UDCA)
干预措施: Ursodeoxycholic acid (UDCA) (Drug)
Ursodeoxycholic acid (UDCA) Placebo
Drug: Placebo Placebo tablets, oral administration, multiple administrations
Arms: Placebo
干预措施: UDCA Placebo (Drug)
结局指标
主要结局
Composite of Pharmacokinetics
时间窗: Multiple blood sample will be collected for 24 hours after last dosing in each of the periods
Accumulation index
次要结局
- [Safety & tolerability] Incidence of adverse events related with drug(4 weeks)