NCT02374684已完成1 期
A Within-group Randomized, Double-Blind, Placebo-Controlled, Single/ Multiple Dose Study to Assess the Safety , Tolerability, Pharmacokinetics and Food Effect of Methosulide After Oral Administration In Healthy Adult Subjects.
Hubei Biological Medicine Industrial Technology Institute Co., Ltd.1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single and repeated oral administration of Methosulide 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 and food effect of Methosulide after oral administration in healthy adult subjects.
详细描述
- Dose-escalation study of single oral administration of Methosulide in healthy adults to assess the safety and tolerability.
- Multiple-dose study of Methosulide in healthy adults to assess the safety and tolerability.
- Dose-escalation study of single oral administration of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics
- Multiple-dose study of Methosulide in healthy adults to evaluate the pharmacokinetics characteristics
- Single dose,and cross-over study of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics and effect of food.
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 19～25 kg/m2, Weight > or = 50kg
- •In good health as judged by the investigator
- •Without history of medication within 2 weeks before the test
- •Non-allergic constitution, without known drug allergy
- •Without history of major organ diseases
- •Without other factors affecting drug metabolism, such as smoking (within 2 weeks), drinking (within 2 weeks), or drug abuse history
- •Signed informed consent form and Fully understood the contents, process and possible adverse reactions of the test
排除标准
- •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: blood system, renal disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, allergic diseases (including drug allergy, but not including non-treatment, asymptomatic, seasonal allergy during the period of oral administration)
- •History of abuse of Smoking, alcohol, or other drugs
- •Severe hemorrhage factors to affect the venous blood collection
- •Severe blood loss or blood donation within 3 months before the test
- •Participation in other drug trials within 3 months before the test
- •Usage of drugs known to have damage to the main organs within 3 months before the test
- •Without good compliance, or unable to match with 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
- •For childbearing-aged women only, usage of any hormonal contraceptive methods within 3 months before the drug administration; or unable or unwilling to use non-hormonal contraceptive methods to contraception from the day of dosing until 14 days after dosing
- •Be otherwise unsuitable for the study, in the opinion of the Investigator.
研究组 & 干预措施
Methosulide
Experimental
Methosulide, oral administration
干预措施: Methosulide (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 Methosulide as measured by the frequency of drug-related clinical adverse events in healthy adults.
时间窗: Period I: single dose,Baseline - 7 Days;Period II: repeated dose,Baseline - 14 Days
Adverse events, vital signs, electrocardiograms, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment
次要结局
- Cmax of single oral administration of Methosulide and effect of food in healthy adults.(Baseline - 7 Days)
- Tmax of single oral administration of Methosulide and effect of food in healthy adults.(Baseline - 7 Days)
- area under curve(AUC) of single oral administration of Methosulide and effect of food in healthy adults.(Baseline - 7 Days)
- t1/2α of single oral administration of Methosulide and effect of food in healthy adults.(Baseline - 7 Days)
- t1/2β of single oral administration of Methosulide and effect of food in healthy adults.(Baseline - 7 Days)
- Vd of single oral administration of Methosulide and effect of food in healthy adults.(Baseline - 7 Days)
- Cls of single oral administration of Methosulide and effect of food in healthy adults.(Baseline - 7 Days)
- Css of repeated oral administration of Methosulide in healthy adults.(Baseline - 14 Days)
- Cmax of repeated oral administration of Methosulide in healthy adults.(Baseline - 14 Days)
- Tmax of repeated oral administration of Methosulide in healthy adults.(Baseline - 14 Days)
- area under curve(AUC) of repeated oral administration of Methosulide in healthy adults.(Baseline - 14 Days)
- t1/2α of repeated oral administration of Methosulide in healthy adults.(Baseline - 14 Days)
- t1/2β of repeated oral administration of Methosulide in healthy adults.(Baseline - 14 Days)
- Vd of repeated oral administration of Methosulide in healthy adults.(Baseline - 14 Days)
- Cls of repeated oral administration of Methosulide in healthy adults.(Baseline - 14 Days)
研究者
研究点 (1)
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