Safety of Total Daily Doses of 5, 10, 15 and 20 mL PEG 400 Administered Orally to Healthy Male Human Subjects Once (QD) or Twice (BID) for 14 Days. A Single Center, Multiple Rising Dose Study, Placebo Controlled, Double-blinded at Each Dose Level
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Number of subjects with clinically relevant findings in vital signs
研究概览
简要总结
To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses
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
- Double
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects as determined by results of screening
- •Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
- •Age ≥ 18 and ≤ 55 years
- •Broca ≥ - 20 % and ≤ + 20 %
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram [ECG]) deviating from normal and of clinical relevance
- •History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection
- •History of orthostatic hypotension, fainting spells and blackouts
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) within one month prior to administration
- •Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
- •Participation in another trial with an investigational drug within one month prior to administration or during the trial
- •Smoker (> 10 cigarettes or three cigars or three pipes/day) or inability to refrain from smoking 10 hours before the morning dose and one hour before afternoon/evening dose and one hour after any dose
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation within one month prior to administration or during the trial
- •Excessive physical activities within five days prior to administration or during the trial
- •Any laboratory value outside the clinically accepted reference range and of clinical relevance
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
PEG 400
multiple rising doses
干预措施: PEG 400 (Drug)
结局指标
主要结局
Number of subjects with clinically relevant findings in vital signs
时间窗: up to 7 days after last drug administration
blood pressure, pulse rate
Number of subjects with clinically relevant findings in physical examination
时间窗: up to 7 days after last drug administration
Number of subjects with adverse events
时间窗: up to 7 days after last drug administration
Number of subjects with clinically relevant findings in laboratory tests
时间窗: up to 7 days after last drug administration
Number of subjects with clinically relevant findings in 12-lead ECG
时间窗: up to 7 days after last drug administration
Assessment of global tolerability by the investigator on a 4-point rating scale
时间窗: up to 7 days after last drug administration
次要结局
未报告次要终点