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

2018-12-21 04:43:11 | BioPortfolio

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.

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

Study Design

Conditions

Healthy Volunteer Study

Intervention

Tranexamic Acid 1 gram intravenously, Tranexamic acid 2 grams oral solution, Tranexamic acid 1 gram intramuscular

Location

UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines
Montigny-Le-Bretonneux
France
78180

Status

Not yet recruiting

Source

London School of Hygiene and Tropical Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2018-12-21T04:43:11-0500

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Medical and Biotech [MESH] Definitions

Antifibrinolytic hemostatic used in severe hemorrhage.

The reversibly oxidized form of ascorbic acid. It is the lactone of 2,3-DIKETOGULONIC ACID and has antiscorbutic activity in man on oral ingestion.

Measurement of this acid in the urine after oral administration of histidine provides the basis for the diagnostic test of folic acid deficiency and of megaloblastic anemia of pregnancy.

Carbonic acid (H2C03). The hypothetical acid of carbon dioxide and water. It exists only in the form of its salts (carbonates), acid salts (hydrogen carbonates), amines (carbamic acid), and acid chlorides (carbonyl chloride). (From Grant & Hackh's Chemical Dictionary, 5th ed)

A 20-carbon-chain fatty acid, unsaturated at positions 8, 11, and 14. It differs from arachidonic acid, 5,8,11,14-eicosatetraenoic acid, only at position 5.

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