NCT02538003已完成1 期
A Randomized, Open-label, Single Dose, Crossover, Phase Ⅰ Trial to Evaluate the Effect of Food on the Pharmacokinetics of LCB01-0371 in Healthy Male Subjects
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
- 30
- 试验地点
- 1
- 主要终点
- Number of Adverse events
研究概览
简要总结
The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.
详细描述
A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.
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
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male between 20 and 40 years of age at the time of screening with body mass index (BMI) between 19 kg/m2 and 28 kg/m2 at the time of screening
- •Appropriated for a medical examination by interview,Vital sign,physical examination, local laboratory test result and 12-lead ECG
- •Capable of performing follow up visit, blood sampling
- •Agree to continue to use a medically reliable dual contraception and not to donate sperm in this protocol for the duration of the study and for 28 days after last dose of investigational product
- •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 clinically significant disease such as digestive system, respiratory, musculoskeletal, cardiovascular, endocrine, neuropsychiatry, hematology, cardiovascular system
- •History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 180 days possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
- •History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics(except non active allergic rhinitis)
- •History of drug abuse or positive result at urine drug screening test at screening visit
- •Intake drug which expected to chronic influence of drug absorption or elimination within 30 days prior to screening visit
- •Other: Patients considered unable perform for the study by the investigator concerning
研究组 & 干预措施
Group 1(RT):LCB01-0371 Tablet 800mg
Experimental
- Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal)
- Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal)
干预措施: LCB01-0371 Tablet 800 mg(R) (Drug)
Group 1(RT):LCB01-0371 Tablet 800mg
Experimental
- Period:LCB01-0371 Tablet 800mg(Reference: Taken drug before meal)
- Period: LCB01-0371 Tablet 800 mg(Test: Taken drug after meal)
干预措施: LCB01-0371 Tablet 800 mg(T) (Drug)
Group 2(TR):LCB01-0371 Tablet 800mg
Experimental
- Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal)
- Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal)
干预措施: LCB01-0371 Tablet 800 mg(R) (Drug)
Group 2(TR):LCB01-0371 Tablet 800mg
Experimental
- Period:LCB01-0371 Tablet 800mg(Test:taken drug after meal)
- Period: LCB01-0371 Tablet 800 mg(Reference:taken drug before meal)
干预措施: LCB01-0371 Tablet 800 mg(T) (Drug)
结局指标
主要结局
Number of Adverse events
时间窗: From date of randomization until follow up after 7 days from last hospital discharge
次要结局
- Pharmacokinetics: AUClast(Area under the plasma concentration)(0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours)
- Pharmacokinetics: Cmax(Peak plasma concentration)(0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours)
研究者
研究点 (1)
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