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

Centre of Clinical Pharmacology, Hanoi Medical University

Status and phase

Completed

Phase 1

Conditions

Bioequivalence

Treatments

Drug: JAPROLOX TABLET

Drug: FABALOFEN 60

Study type

Interventional

Funder types

Other

Identifiers

NCT04386122

CCP2018-BE.07

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males.
18 to 55 years old.
BMI in the range of 18 - 27 kg/m2, according to 1983 Metropolitan Index for adults.
No present or history of hypertension, diabetes, respiratory or digestive problems, hepatic or renal deficiency, genetic problems nor tuberculosis (all inclusive).
Laboratory results (hematological, biological) within normal range; negative HIV-test and HbsAg.
No abnormalities on ECG.
Willing to participate in the study.

Exclusion criteria

Legal incompetency.
Drug, alcohol or tobacco abuse.
Allergic history to loxoprofen or any other excipients of the study products, or heparin.
Abnormalities in cardiovascular, digestive, immunity, hematological, endocrine, neurological or psychiatric system determined by clinical physicians.
Suspected positive HIV-test or HbsAg by quick test or electrochemiluminescence Immunoassay (ECLIA) or enzyme-linked immunosorbent assay (ELISA).
Any illness determined by clinical physicians within 2 weeks prior to the first dosing.
Use of any over-the-counter drug within 1 week or prescription drug within 2 weeks prior to the first dosing.
Donation or loss of more than 450 ml of blood within 28 days prior to the first dosing.
History of dysphagia or digestive diseases affecting drug absorption.
History of difficulty in accessibility of veins in arms.