NCT06592300

Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects

An Open Label, Balanced, Randomized, Two-sequence, Two-treatment, Four -Period, Single Oral Dose, Fully Replicate,Bioequivalence Study in Normal, Healthy, Adult, Human Subjects Under Fed Condition.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (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, fully replicate, bioequivalence study in normal, healthy, adult, human subjects under fed condition.

Conditions

• Chronic Hepatitis B in Adults and Paediatric Patients

Interventions

Type	Name	Description
DRUG	Tenofovir Alafenamide Film coated Tablet	The administration was performed in the morning, 30 minutes after a high-fat, high-calorie vegetarian breakfast was served following an overnight fast of at least 10 hours.
DRUG	Vemlidy® film-coated tablets	The administration was performed in the morning, 30 minutes after a high-fat, high-calorie vegetarian breakfast was served following an overnight fast of at least 10 hours.

Timeline

• Start date: 2024-07-06
• Primary completion: 2024-08-02
• Completion: 2024-09-13
• First posted: 2024-09-19
• Last updated: 2025-04-18

Locations

1 site across 1 country: India