NCT06043297

Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Oral Dose, Cross Over Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Normal, Healthy, Adult, Human Subjects Under Fasting Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under fasting condition and to assess the bioequivalence.

Conditions

• Antithrombic Drug

Interventions

Type	Name	Description
DRUG	Apixaban 5MG	Each film-coated tablet contains 5 mg apixaban
DRUG	Eliquis 5 mg	Each film-coated tablet contains 5 mg apixaban

Timeline

• Start date: 2023-02-23
• Primary completion: 2023-03-06
• Completion: 2023-04-27
• First posted: 2023-09-21
• Last updated: 2025-09-15

Locations

1 site across 1 country: India