An Open-Label, Single-dose Administration Study of the Pharmacokinetics and Pharmacodynamics of Higenamine, Administered Intravenously Injection to Healthy Chinese Subjects

Peking Union Medical College Hospital1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2009年6月最近更新: 2011年10月13日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Peking Union Medical College Hospital
入组人数: 10
试验地点: 1
主要终点: The maximum observed plasma concentration

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of higenamine in healthy Chinese subjects

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 19 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Subjects must meet all the following inclusion criteria to be eligible to participate in this study:
•Chinese healthy adult males, female subjects (either gender the proportion of not less than 1 / 3).
•Age: 19 to 45 (including 19, 45) years old.
•Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index within the normal range (weight (kg) / height 2 (m2) = 18-25).
•Informed consent form is obtained.

排除标准

•Subjects will be excluded from entry if any of the criteria listed below are met:
•Presence or history of any disorder of cardiovascular system, respiratory system, digestive system, urogenital system, endocrine system, allergy / immune system, blood system, nervous / mental system, musculoskeletal system, skin diseases.
•History of any drug hypersensitivity.
•Female urine pregnancy test was positive.
•Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and/or hepatitis C virus (HCV) antibodies.
•Acute disease state or infection associated with prescription drugs within 1 month before study day
•Taking any drugs, including over-the-counter drugs and herbal supplements within 7 days before study day
•History of alcohol abuse (consuming greater than 14 glasses of alcoholic beverages each week, 1 glass is approximately equivalent to: beer 284 mL, wine 125 mL, or distilled spirits [25 mL).
•History of drug abuse.
•Smoker or subjects quitting smoking less than 1 month before study day
•Participating other trials within 1 month before study day
•Donating blood (> 400 mL) within 1 month before study day
•During screening, alcohol breath test result > 0.
•Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
•Heart rate was lower than 45 beats per minute (bpm) and/or higher than 90 bpm during rest.
•The investigator thought the subjects might not be able to complete the study or comply with the requirements of the study (due to management reasons or other reasons).