NCT03777488

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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 (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

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Tranexamic Acid 1 gram intravenously	Intravenous tranexamic acid crossover to oral and intramuscular arms
DRUG	Tranexamic acid 2 grams oral solution	Oral tranexamic acid crossover to intravenous and intramuscular arms
DRUG	Tranexamic acid 1 gram intramuscular	Intramuscular tranexamic acid crossover to oral and intravenous arms

Timeline

• Start date: 2019-10-30
• Primary completion: 2020-10-14
• Completion: 2020-10-14
• First posted: 2018-12-17
• Last updated: 2020-11-18

Locations

2 sites across 1 country: France