Pharmacokinetics of Tranexamic Acid: a randomised trial in healthy volunteers.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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