NCT06930937

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

An Open Label, Randomized, Four-period, Twotreatment, Two-sequence, Fully Replicate, Crossover, Balanced, Single Dose Oral Bioequivalence Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
OTHER	Lixiana® Film Coated Tablet	Lixiana® 60 mg filmtabletten (Film Coated Tablet) (Edoxaban)
OTHER	Edoxaban Film Coated Tablet	Edoxaban 60 mg Film Coated Tablet

Timeline

• Start date: 2024-08-30
• Primary completion: 2024-10-25
• Completion: 2024-11-11
• First posted: 2025-04-16
• Last updated: 2025-04-20

Locations

1 site across 1 country: India