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

NCT03777488 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-11-18

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer Study

Interventions

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

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Haleema Shakur-Still · London School of Hygiene and Tropical Medicine

  • Ian Roberts · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777488 on ClinicalTrials.gov