NCT04386122

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

An in Vivo Bioequivalence Study of FABALOFEN 60 (Loxoprofen Sodium 60mg/Tablet) of Pharbaco Central Pharmaceutical J.S.C No.I With JAPROLOX® TABLETS (Loxoprofen Sodium 60mg/Tablet) of Daiichi Sankyo Propharma Co., Ltd

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate whether FABALOFEN 60 is bioequivalent to JAPROLOX® TABLETS after a single oral administration of each loxoprofen formulation in healthy subjects by assessing of pharmacokinetic properties including AUC, Tmax and Cmax and to evaluate the safety of test drug FABALOFEN 60 and reference drug JAPROLOX® TABLETS during drug administration.

Detailed description

This study is a randomized, single-dose, 2-sequence, 2-period, 2-treatment crossover study in 24 fed healthy subjects with an at-least-6-day washout period. The drug level in serum is detected by High-performance Liquid Chromatography (HPLC) to determine Cmax, AUC0-t and Tmax. Safety are evaluated during drug administration, blood sampling time, washout period and 1 week after the end of blood sampling for any adverse drug reactions.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-05-07
• Primary completion: 2020-05-17
• Completion: 2020-05-31
• First posted: 2020-05-13
• Last updated: 2021-03-18

Locations

1 site across 1 country: Vietnam