NCT00629733已完成1 期
Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers
Rovi Pharmaceuticals Laboratories1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007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
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers
研究概览
简要总结
Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers: male subjects aged between 18 and 45 years
- •Body weight: 65-75 Kg
- •Not meaningful abnormalities in physical examination and in clinical history
- •Without evidence of significant organic or psychiatric illness
- •Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
- •Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
- •Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
- •Not give blood in the last 4 weeks.
- •Healthy male volunteers who have not received heparin in the past
- •Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent
排除标准
- •Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
- •Important consumption of exciting drinks: alcohol consumption > 30 g/day; coffee, tea, cola > 5 /day
- •Allergy, idiosyncrasy or hypersensitivity to medicines
- •Healthy volunteers who are receiving another medication in the past 15 days
- •Positive serology of hepatitis B, C or HIV
- •Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
- •Mayor Surgery in the last 6 months
- •Smoking > 10 cigarettes / day
- •Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine
- •Healthy volunteers with a familiar history evident hemorrhagic episodes
研究组 & 干预措施
Ro-14
Experimental
干预措施: RO-14 (Drug)
结局指标
主要结局
Main objective : To evaluate safety and tolerability of increasing single-doses to healthy male volunteers
时间窗: safety parameters
次要结局
- Secondary objectives : To evaluate pharmacokinetics profiles of each of single-doses.(anti-Xa activity)
研究者
研究点 (1)
Loading locations...
相似试验
终止
1 期
Study to Assess Tolerability, Safety and Pharmacokinetics of a New DrugHealthyNCT01702675Ache Laboratorios Farmaceuticos S.A.22
已完成
1 期
A Trial of SHR6508 in Secondary HyperparathyroidismSecondary HyperparathyroidismNCT05221008Shanghai Hengrui Pharmaceutical Co., Ltd.54
已完成
1 期
Multiple Ascending Dose Trial of BYK324677 in Healthy VolunteersType 2 Diabetes MellitusNCT01386541Nycomed36
招募中
4 期
Letermovir for Secondary Prophylaxis in Solid Organ Transplant RecipientsCytomegalovirus InfectionsInfection in Solid Organ Transplant RecipientsNeutropeniaAntiviral ToxicityNCT05626530Tufts Medical Center25
已完成
1 期
A Study to Look at How Safe NNC0268-0965 is in Healthy People and People With Type 1 DiabetesHealthy VolunteersDiabetes Mellitus, Type 1NCT03965013Novo Nordisk A/S78