Healthy Volunteer Study Clinical Trial
Official title:
Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.
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 ;
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Completed |
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