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

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University
• Treatments: Loxoprofen

Criteria

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.