NCT01685671已完成1 期
A Randomized, Double-blind, Active Control, Single Dosing, Crossover Clinical Trial to Investigate the Pharmacokinetics of CKD-11101 and NESP After SC Administration in Health 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
- 34
- 试验地点
- 1
- 主要终点
- Assess Cmax of darbepoetin alfa
研究概览
简要总结
The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after SC administration in health male volunteers
详细描述
Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once subcutaneously. (crossover) Every time before and after taking each medication, PK parameters and safety of CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some tests(Laboratory test, V/S and Physical Examination, etc) respectively.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed the informed consent form prior to study participation.
- •A healthy male volunteer between 20 and 55 years old.
- •Body weight between 55kg and 90kg, BMI between 18 and
- •Appropriate subject for the study judging from investigator(physical examination, laboratory test, interview, etc.)
排除标准
- •Have the medical history of allergic diseases including hypersensitivity against drug or clinically significant allergic diseases
- •Clinically significant hepatic, renal, respiratory system, endocrine system, nervous system, immune system, hematologic, psychiatric, circulatory system, tumor or have history of tumor
- •Have abnormal laboratory result.
- •Hemoglobin < 12g/dL or > 17g/dL
- •Vitamin B12 < 200pg/mL
- •Ferritin < 21.8ng/mL
- •Transferrin < 190mg/dL
- •Reticulocyte over the normal limit
- •Positive for the Triage TOX drug on urine (cocaine, amphetamines, barbiturates, opiates, benzodiazepine, cannabinoids)
- •Positive for HIV antibody, HBsAg, HCV antibody test
- •A heavy smoker (cigarette > 10 cigarettes per day)
- •Administer EPO, darbepoetin, immunoglobulin or IV iron within 3 months prior to the first IP administration
- •Have hypersensitivity reactions history for EPO, darbepoetin, excipient of IP or iron tablets
- •sit SBP < 90mmHg or sit SBP > 140mmHg or sit DBP < 55mmHg or sit DBP > 90mmHg or Pulse rate > 100 per/min
- •History of hemoglobinopathy or inflammatory disease or drug abuse within 6 months before screening
- •Subject takes ethical drug or herbal medicine within 14 days, OTC or vitamin supplements within 7 days before the first IP administration
- •Participated in the other clinical trials and administrated IP within 8 weeks prior to the first IP administration
- •A heavy alcohol consumer (alcohol > 21 units/week) or cannot stop drinking
- •Bleed or donate blood (> 400mL) within 8 weeks before the first IP administration
- •Participated in this clinical trials and administrated IP
- •Have a diet within 2 days before the first IP administration or cannot stop having
- •food containing grapefruit
- •food containing caffeine
- •Disagree to avoid getting pregnant during clinical trial
- •An impossible one who participates in clinical trial by investigator's decision including laboratory test result, other reason
研究组 & 干预措施
CKD-11101 60μg
Experimental
Prefilled syringe filled with Darbepoetin alfa 60μg
干预措施: CKD-11101 60μg (Drug)
NESP 60μg
Active Comparator
Prefilled syringe filled with Darbepoetin alfa 60μg
干预措施: NESP 60μg (Drug)
结局指标
主要结局
Assess Cmax of darbepoetin alfa
时间窗: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
Assess AUClast of darbepoetin alfa
时间窗: Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h
次要结局
- Assess Tmax of darbepoetin alfa(Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h)
- Assess AUCinf of darbepoetin alfa(Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h)
- Assess t1/2 of darbepoetin alfa(Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h)
- Assess CL of darbepoetin alfa(Pre-dose, 1h, 2h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 168h, 216h, 264h, 360h)
研究者
研究点 (1)
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