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

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.

Study Overview

• Status: Completed
• Conditions: Bioequivalence
• Intervention / Treatment: Drug: FABALOFEN 60; Drug: JAPROLOX TABLET

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam
    • Centre of Clinical Pharmacology, Hanoi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FABALOFEN 60; Subjects will receive a single dose of 1 FABALOFEN 60 tablet under fed condition	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; Other Names: Loxoprofen sodium 60mg/tablet
Active Comparator: JAPROLOX TABLET; Subjects will receive a single dose of 1 JAPROLOX® TABLETS tablet under fed condition	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; Other Names: Loxoprofen sodium 60mg/tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Area under the plasma concentration curve from time 0 to the last measured (AUC0-t). Analyzing AUC with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population mean with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25.	Up to 8 hours post-administration
Cmax	Maximum plasma concentration. Analyzing Cmax with ANOVA test to evaluate the 90% confidence interval for the ratio (Test/Reference) of the population means with a logarithmic transformation prior to analysis with acceptance interval of 0.80 - 1.25.	Up to 8 hours post-administration
Tmax	Time until Cmax is reached. Tmax is analyzed with Wilcoxon non-parametric test	Up to 8 hours post-administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	The number and type of adverse events will be reported from first drug administration (period 1) till 1 week after the second drug administration (period 2), including 6 days of washout period (total time is approximately 14 days)	Up to approximately 14 days

Collaborators and Investigators

• Sponsor: Centre of Clinical Pharmacology, Hanoi Medical University
• Investigators: Principal Investigator: Thanh P Nguyen, MD, Centre of Clinical Pharmacology, Hanoi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Actual): May 17, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Loxoprofen
• Other Study ID Numbers: CCP2018-BE.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No