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

Phase 1 Completed 15 enrolled London School of Hygiene and Tropical Medicine

RandomizedCrossoverOpen-labelOther

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 intravenous administration. It will also determine the feasibility of measuring tranexamic acid in spots of dry capillary blood.

Timeline

Start: 2019-10-30
Primary completion: 2020-10-14
Completion: 2020-10-14

Publications

Grassin-Delyle S, Semeraro M, Lamy E, Urien S, Runge I, Foissac F, Bouazza N, Treluyer JM, Arribas M, Roberts I, Shakur-Still H. Pharmacokinetics of tranexamic acid after intravenous, intramuscular, and oral routes: a prospective, randomised, crossover trial in healthy volunteers. Br J Anaesth. 2022 Mar;128(3):465-472. doi: 10.1016/j.bja.2021.10.054. Epub 2022 Jan 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tranexamic Acid	Small molecule	1 g	Intravenous
Subject	Tranexamic Acid	Small molecule	2 g	Intravenous

Indications

No indication recorded.