An in Vivo Bioequivalence Study of 2 Loxoprofen Sodium Products in Vietnamese Healthy Male Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 7, 2020

Primary Completion Date

May 17, 2020

Study Completion Date

May 31, 2020

Conditions
Bioequivalence
Interventions
DRUG

FABALOFEN 60

Dosage: Single dose of one tablet of test product in each period. Administration: 30 minutes before administration, subjects will receive a test meal (high-fat and high-calorie) and finish this meal in 30 minutes or less. Take 1 tablet of test product with 240 mL of water. Lying position or strenuous activities are not allowed within 2 hours post dose

DRUG

JAPROLOX TABLET

Dosage: Single dose of one tablet of reference product in each period. Administration: 30 minutes before administration, subjects will receive a test meal (high-fat and high-calorie) and finish this meal in 30 minutes or less. Take 1 tablet of reference product with 240 mL of water. Lying position or strenuous activities are not allowed within 2 hours post dose

Trial Locations (1)

Unknown

Centre of Clinical Pharmacology, Hanoi Medical University, Hanoi

All Listed Sponsors
lead

Centre of Clinical Pharmacology, Hanoi Medical University

OTHER

NCT04386122 - An in Vivo Bioequivalence Study of 2 Loxoprofen Sodium Products in Vietnamese Healthy Male Volunteers | Biotech Hunter | Biotech Hunter