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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
15
Intravenous tranexamic acid crossover to oral and intramuscular arms
Oral tranexamic acid crossover to intravenous and intramuscular arms
Intramuscular tranexamic acid crossover to oral and intravenous arms
UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines
Montigny-le-Bretonneux, France
Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades
Paris, France
Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)
Time frame: 24 hours
Pain during after administration (visual analogue scale) for each administration route
(Scale 0 - 9) where 0 = no pain and 9 most severe pain
Time frame: 8 hours
Reaction at site of injection for intramuscular and Iintravenous routes
Time frame: 24 hours
• Correlation between serum and dry blood spot concentrations for each administration route
Time frame: 24 hours
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