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To Compare and Evaluate the Oral Bioavailability of Edoxaban 60 mg Film Coated Tablet With That of Lixiana® 60 mg Filmtabletten (Film Coated Tablet) (Edoxaban) in Healthy, Adult, Human Subjects Under Fasting Conditions

NCT06930937 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-04-20

No results posted yet for this study

Summary

* To compare and evaluate the oral bioavailability of Edoxaban 60 mg Film Coated Tablet with that of Lixiana® 60 mg filmtabletten (Film Coated Tablet (Edoxaban) in healthy, adult, human subjects under fasting conditions.
* To monitor the safety and tolerability of the subjects.

Conditions

  • Prevention of Stroke or Systemic Embolism
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism (PE)

Interventions

OTHER

Lixiana® Film Coated Tablet

Lixiana® 60 mg filmtabletten (Film Coated Tablet) (Edoxaban)

OTHER

Edoxaban Film Coated Tablet

Edoxaban 60 mg Film Coated Tablet

Sponsors & Collaborators

  • Humanis Saglık Anonim Sirketi

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2024-10-25
Completion
2024-11-11

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930937 on ClinicalTrials.gov