NCT00959777已完成1 期
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy 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
- 试验地点
- 1
研究概览
简要总结
The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031 (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were investigated in healthy volunteers. PK/PD of filgrastim (Dong-A) following repeated dose delivered by SC injection were investigated in healthy volunteers. PK/PD from a single dose of DA-3031 and repeated dose of filgrastim (Dong-A) were compared.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy males subjects, 20-40 years inclusive
- •weight 60-75 kg inclusive and Ideal Body Weight (IBW) between -15% and +15% inclusive
- •Written informed consent given
- •Willing and able to comply with the requirements of the protocol
排除标准
- •Hypersensitivity to drugs(aspirin, antibiotics and so on)
- •History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, hematological, oncological pathology
- •Have a history of drug abuse, or show positive for drug abuse at urine screening
- •Have participated in another clinical study within 2 months prior to entering inth the study
- •Have been persistently drinking alcohol or can not stop drinking alcohol during the study
- •Smokers whose average smoke for last 3 months is more than 10 cigarettes/day
- •Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons
研究组 & 干预措施
DA-3031
Experimental
干预措施: DA-3031 (Drug)
filgrastim
Active Comparator
干预措施: Filgrastim (Drug)
研究者
研究点 (1)
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