Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.

London School of Hygiene and Tropical Medicine2 个研究点分布在 1 个国家目标入组 15 人开始时间: 2019年10月30日最近更新: 2020年11月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: London School of Hygiene and Tropical Medicine
入组人数: 15
试验地点: 2
主要终点: Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)

研究概览研究设计入排标准研究组 & 干预措施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

This is a Phase 1 study which aims to determine the pharmacokinetics and local and systemic tolerance of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration. It will also determine the feasibility of measuring tranexamic acid in spots of dry capillary blood.

详细描述

Fifteen healthy volunteers will receive in random order 1 gram of intravenous and intramuscular injections and 2 grams of oral tranexamic acid solution. Blood samples will be taken at:

T0+ 5min (only for IV route)
T0+30min
T0+1h
T0+2h
T0+3h
T0+4h
T0+5h
T0+6h
T0+8h (only for IM and PO routes)
T0+24h

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: None

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

•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 renal function based on medical history and laboratory tests
•If a woman, must have a negative urine β-human chorionic gonadotropin (βhCG) pregnancy test at screening and inclusion visits
•Provision of signed informed consent prior to any study specific procedure
•People with public healthcare insurance (in France)

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
•Known allergy 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:
•People deprived of liberty by judicial or administrative decision
•Adult protected by law (France)