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

PHASE1CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

July 6, 2024

Primary Completion Date

August 2, 2024

Study Completion Date

September 13, 2024

Conditions
Chronic Hepatitis B in Adults and Paediatric Patients
Interventions
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.

Trial Locations (1)

382481

Lambda Therapeutic Research Ltd., Ahmedabad

All Listed Sponsors
lead

Humanis Saglık Anonim Sirketi

INDUSTRY

NCT06592300 - Bioequivalence Study of Two Products of Tenofovir Alafenamide 25 mg Film Tablet in Healthy, Adult, Human Subjects | Biotech Hunter | Biotech Hunter