NCT02622230Unknown1 期
A Randomized, Double-Blind, Placebo-Controlled, Single/ Multiple Dose Study to Assess the Safety , Tolerability, Pharmacokinetics of Mianhuahua Flavonoids Tablets After Oral Administration In Healthy Adult Subjects
Xinjiang Uygur Pharmaceutical Co., Ltd.0 个研究点目标入组 60 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 主要终点
- Safety and tolerability of single and repeated oral administration of Mianhuahua Flavonoids Tablets as measured by the frequency of drug-related clinical adverse events in healthy adults.
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics of Mianhuahua Flavonoids Tablets after oral administration in healthy adult subjects.
详细描述
- Dose-escalation study of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults to assess the safety and tolerability.
- Multiple-dose study of Mianhuahua Flavonoids Tablets in healthy adults to assess the safety and tolerability.
- Dose-escalation study of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults to evaluate the pharmacokinetic characteristics
- Multiple-dose study of Mianhuahua Flavonoids Tablets in healthy adults to evaluate the pharmacokinetics characteristics
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～24 kg/m2, Weight > or = 50kg
- •In good health as judged by the investigator
- •Agreed to take effective contraceptive measures during the test and within 6 months after the last drug administration
- •Signed informed consent form and fully understood the contents, process and possible adverse reactions of the test
排除标准
- •Pregnancy and lactation
- •History of kinds of food or drug allergy, or suffering from allergic diseases or allergic constitution
- •Presence (in screening stage) or history of the acute/chronic organic diseases or clinical manifestations: Including but not limited to blood system, renal disease, liver disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, or any disease and physiological conditions interfering with the results of the test
- •with a clinically significant abnormality in routine serological detection: including Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infected
- •History of abuse of drugs, or the result of drug abuse test is positive
- •Alcohol intake more than 2 units (1 unit is equal to 12 ounces or 360 ml beer, 5 ounces or 150 ml liquor, 1.5 ounces or 45 ml distilled spirits ) per day on average within 3 months before the test, or the result of alcohol test is positive
- •Smoking more than 5 cigarettes per day, or using quite amount of nicotine products within 3 months before the test, or unable to stop smoking during the test
- •Excessive consumption of xanthine soda drinks, more than four cups or bottles per day
- •With major surgical operations and blood or blood component transfusion within 4 weeks before the test
- •Severe blood loss or blood donation more than 400ml within 2 months before the test
- •Participation in other drug trials within 3 months before the test
- •Usage of any drugs within 2 weeks before the test, or within 5 times of drug eliminated half-life or pharmacodynamics half-life; Vaccination within 4 weeks before the test; Acceptance of biological agents within 4 months before the test
- •Be otherwise unsuitable for the study, in the opinion of the Investigator.
研究组 & 干预措施
Mianhuahua Flavonoids Tablets
Experimental
Mianhuahua Flavonoids Tablets, oral administration
干预措施: Mianhuahua Flavonoids Tablets (Drug)
Placebo
Placebo Comparator
Placebo, oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of single and repeated oral administration of Mianhuahua Flavonoids Tablets as measured by the frequency of drug-related clinical adverse events in healthy adults.
时间窗: Period I: single dose,up to 7 Days;Period II: repeated dose,up to 36 Days
Safety and tolerability will be evaluated through Composite Metrics：adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments.
次要结局
- Cmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 24h)
- Degree of fluctuation（DF） of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 29 days)
- Css_min of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 29 days)
- area under curve of steady state(AUCss) of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 29 days)
- area under curve(AUC) of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 24h)
- Tmax of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 24h)
- t1/2 of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 24h)
- Tss_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 29 days)
- Vd of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 24h)
- Cls of single oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 24h)
- Css_max of repeated oral administration of Mianhuahua Flavonoids Tablets in healthy adults.(up to 29 days)
研究者
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