Who is sponsoring NCT03777488?

NCT03777488 is sponsored by London School of Hygiene and Tropical Medicine.

What drugs are being tested in NCT03777488?

Interventions in NCT03777488: Tranexamic Acid 1 gram intravenously, Tranexamic acid 2 grams oral solution, Tranexamic acid 1 gram intramuscular.

What condition does NCT03777488 study?

NCT03777488 studies Healthy Volunteer Study.

Is NCT03777488 still recruiting?

NCT03777488 is currently completed. Last updated 18 November 2020.

Last reviewed 2020-11-18 · How we verify

NCT03777488: PharmacoTXA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 18 November 2020

What this trial tests

Phase 1 trial testing Tranexamic Acid 1 gram intravenously in Healthy Volunteer Study in 15 participants. Completed in 14 October 2020.

Timeline

30 October 2019

Primary endpoint
14 October 2020

14 October 2020

Quick facts

Lead sponsor	London School of Hygiene and Tropical Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	15
Start date	30 October 2019
Primary completion	14 October 2020
Estimated completion	14 October 2020
Sites	2 locations across France

Drugs / interventions tested

Tranexamic Acid 1 gram intravenously — full drug profile →
Tranexamic acid 2 grams oral solution — full drug profile →
Tranexamic acid 1 gram intramuscular — full drug profile →

Conditions studied

Healthy Volunteer Study — all drugs for Healthy Volunteer Study →

Sponsor

London School of Hygiene and Tropical Medicine

Who can join

Adults 18 to 45, any sex, with Healthy Volunteer Study. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Pharmacokinetics of tranexamic acid after intravenous, intramuscular, and oral routes: a prospective, randomised, crossover trial in healthy volunteers.
Grassin-Delyle S, Semeraro M, Lamy E, Urien S, et al · · 2022 · cited 55× · PMID 34998508 · DOI 10.1016/j.bja.2021.10.054
WOMAN-PharmacoTXA trial: Study protocol for a randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral administration of tranexamic acid in women giving birth by caesarean section.
Arribas M, Roberts I, Chaudhri R, Geer A, et al · · 2021 · cited 10× · PMID 34250266 · DOI 10.12688/wellcomeopenres.16884.1
Clinical Validation of a Volumetric Absorptive Micro-Sampling Device for Pharmacokinetic Studies With Tranexamic Acid.
Grassin-Delyle S, Lamy E, Semeraro M, Runge I, et al · · 2021 · cited 9× · PMID 34887763 · DOI 10.3389/fphar.2021.764379
Evaluating re-identification risks scores in publicly available clinical trial datasets: Insights and implications.
Rodriguez A, Williams LJ, Lewis SC, Sinclair P, et al · · 2025 · cited 1× · PMID 40844227 · DOI 10.1177/17407745251356423

Verify or expand the search:

Other recruiting trials for Healthy Volunteer Study

Currently open trials in the same condition.

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Other London School of Hygiene and Tropical Medicine trials

Trials by the same sponsor.

NCT06921213 — Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis · Phase 2 · not yet recruiting
NCT06923592 — Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and Madagascar · Phase 3 · recruiting
NCT06833736 — A Health App Using Recipes and Education Components to Facilitate Sustainable and Healthier Diets. · NA · completed
NCT06166498 — Parasite Clearance and Protection From Infection (PCPI) in Zambia · Phase 3 · completed
NCT06173206 — Parasite Clearance and Protection From Infection (PCPI) in Cameroon · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03777488 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by London School of Hygiene and Tropical Medicine
Last refreshed: 18 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03777488.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing