NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers

Blood Coagulation Disorder Clinical Trial

— EdoRot  

Official title:

Relationship of Edoxaban Plamsa Concentration and Blood Coagulation in Healthy Volunteers Using Standard Laboratory Tests and Viscoelastic Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666650
• Other study ID #: T224/2018
• Status: Completed
• Phase: Phase 4
• Start date: November 26, 2018
• Est. completion date: January 8, 2019

Study information

• Verified date: September 2019
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers using standard laboratory tests and viscoelastic analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 8, 2019
• Est. primary completion date: January 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

healthy

Exclusion Criteria:

intolerance of the study drug history of bleeding disorder or similar

Related Conditions & MeSH terms

• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Drug:
• Edoxaban 60 MG
Viscoelastic analysis and standard laboratory tests after edoxaban ingestion

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku	Varsinais-Suomi

Sponsors (2)

Lead Sponsor	Collaborator
Turku University Hospital	Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of edoxaban peak plasma concentrations and viscoelastic analysis	viscoelastic test values and blood coagulation laboratory parameters	1 day