NCT04418388已完成1 期
A Single Center, Open-label Clinical Trial to Evaluate Pharmacokinetic Characteristics and Safety of PBK-1801 After Single Oral Administration in Healthy Korean Women Volunteers
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
- 36
- 试验地点
- 1
- 主要终点
- AUCinf
研究概览
简要总结
The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 19 and 30 kg/m²
- •Subjects are to be in good general health according to medical history, physical examination, electrocardiograph (ECG) recording and clinical laboratory assessments showing no signs clinically significant pathology (A subject with a clinically insignificant abnormality may be included by the discretion of the investigator)
- •Subjects are to have given their written informed consent to participate in the study and to abide by study restrictions
排除标准
- •History or evidence of clinically significant cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological, psychiatric or other major disease
- •Subjects who have any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract other than uncomplicated appendectomy, inflammatory bowel disease).
- •History or current alcohol abuse or drug addiction
- •Subjects who for any reason, are deemed by the Investigator to be inappropriate for this study
研究组 & 干预措施
C
Experimental
干预措施: PBK-1801 (Drug)
A
Experimental
干预措施: PBK-1801 (Drug)
B
Experimental
干预措施: PBK-1801 (Drug)
结局指标
主要结局
AUCinf
时间窗: 5 days
Tmax
时间窗: 5 days
T1/2
时间窗: 5 days
Cmax
时间窗: 5 days
AUClast
时间窗: 5 days
CL/F
时间窗: 5 days
Vd/F
时间窗: 5 days
次要结局
- Number of Participants with Adverse Events(30 days)
研究者
研究点 (1)
Loading locations...
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