Status:
COMPLETED
Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Conditions:
Healthy Volunteer Study
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 (on...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03777488
Start Date
October 30 2019
End Date
October 14 2020
Last Update
November 18 2020
Active Locations (2)
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1
UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines
Montigny-le-Bretonneux, France, 78180
2
Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades
Paris, France, 75743