NCT02882789已完成1 期
A Randomized, Single Blind, Single Dose, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous Dosage Form of LCB01-0371 in Healthy Male 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
- 24
- 试验地点
- 1
- 主要终点
- To assess Peak Plasma Concentration(Cmax) of LCB01-0371
研究概览
简要总结
Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary
• To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Male between 19 and 39 years of age at the time of screening
- •Subjects with body mass index (BMI) between 19 and 27 at the time of screening
- •Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 days of study completion
- •Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements
排除标准
- •History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy
- •History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture etc.
研究组 & 干预措施
LCB01-0371 200mg
Experimental
LCB01-0371 IV 200 mg
干预措施: LCB01-0371 (Drug)
LCB01-0371 400mg
Experimental
LCB01-0371 IV 400 mg
干预措施: LCB01-0371 (Drug)
LCB01-0371 400mg
Experimental
LCB01-0371 IV 400 mg
干预措施: LCB01-0371 400mg (Drug)
LCB01-0371 800mg
Experimental
LCB01-0371 IV 800 mg
干预措施: LCB01-0371 (Drug)
结局指标
主要结局
To assess Peak Plasma Concentration(Cmax) of LCB01-0371
时间窗: through study completion per patient, an average of 8 days (+ - 1 D)
次要结局
未报告次要终点
研究者
研究点 (1)
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