EUCTR2019-000285-38-FR进行中（未招募）1 期
Pharmacokinetics of Tranexamic Acid after oral, intramuscular or intravenous administration: a prospective, randomised, cross-over trial in healthy volunteers. - PharmacoTXA
ondon School of Hygiene and Tropical Medicine0 个研究点目标入组 30 人开始时间: 2019年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult healthy volunteers both men and non-pregnant women
- •=18-=45-year-old
- •Body mass index between =18 and =30 kg/m2, and bodyweight between =50 and =100 kg
- •Coagulation test results of fibrinogen, D-dimers, prothrombin time and a partial thromboplastin time within normal limits at screening
- •Normal limits:
- •fibrinogen [ 1.5 - 3.5 g/L]
- •D-dimers < 500 ng/mL
- •prothrombin time > 70 %
- •partial thromboplastin time < 1.2
- •Normal renal function based on medical history and laboratory tests (laboratory test of serum creatinine should in the range of 0.6–1.1 mg/dL for women and 0.7–1.3 mg/dL for men. Glomerular filtration rate (GFR) should be 90 mL/min/1.73m2 or greater (adjusting for age, sex, weight and ethnicity)
- •If a woman, must have a negative urine ß-human chorionic gonadotropin (ßhCG) pregnancy test at screening and inclusion visits
- •Provision of signed informed consent prior to any study specific procedure
- •People with public healthcare insurance
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Previous thrombotic event or pre-existing pro-thrombotic disease
- •Any history of seizures
- •Any chronic or active cardiovascular or renal disease
- •Planned general anaesthesia or surgery in the 3 months following inclusion
- •Pregnant and/or breastfeeding
- •Visual disturbance
- •Haematuria
- •Known allergy or contraindication to the study drugs or any of the excipients of the formulations
- •Use of any prescription or non-prescription medication (other than hormonal contraception) within 7 days before the first dose of the study drug is scheduled
- •Inability to give informed consent
- •Previous participation during the year in clinical studies compensated for an amount incompatible with participation in this study, verified by recording in the national register of subjects participating in human research trials.
- •Legal criteria:
- •- Patient deprived of liberty by judicial or administrative decision
- •- Adult protected by law
研究者
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