NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers

Phase 4

Completed

• Conditions: Blood Coagulation Disorder
• Interventions: Drug: Edoxaban 60 MG

• Registration Number: NCT03666650
• Lead Sponsor: Turku University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-08
• Study First Submitted QC: 2018-09-08
• Study First Posted: 2018-09-12
• Study Start: 2018-11-26
• Primary Completion: 2019-01-08
• Study Completion: 2019-01-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-13
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

healthy

Exclusion Criteria

intolerance of the study drug history of bleeding disorder or similar

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rotem	Edoxaban 60 MG	-

Primary Outcome Measures

Name	Time	Method
correlation of edoxaban peak plasma concentrations and viscoelastic analysis	1 day	viscoelastic test values and blood coagulation laboratory parameters

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Varsinais-Suomi, Finland