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

NCT04386122 | Completed Phase 1

• 1 other identifier: CCP2018-BE.07
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse Events

  Up to approximately 14 days

Study Arms (2)

FABALOFEN 60

EXPERIMENTAL

Subjects will receive a single dose of 1 FABALOFEN 60 tablet under fed condition

Drug: FABALOFEN 60

JAPROLOX TABLET

ACTIVE COMPARATOR

Subjects will receive a single dose of 1 JAPROLOX® TABLETS tablet under fed condition

Drug: JAPROLOX TABLET

Interventions

FABALOFEN 60 DRUG

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

Also known as: Loxoprofen sodium 60mg/tablet

FABALOFEN 60

JAPROLOX TABLET DRUG

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

Also known as: Loxoprofen sodium 60mg/tablet

JAPROLOX TABLET

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre of Clinical Pharmacology, Hanoi Medical University: lead

Study Sites (1)

Centre of Clinical Pharmacology, Hanoi Medical University

Hanoi, Vietnam

Location

MeSH Terms

Interventions

loxoprofen; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Thanh P Nguyen, MD

  Centre of Clinical Pharmacology, Hanoi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single-dose, 2-sequence, 2-period, 2-treatment crossover study

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 13, 2020
• Study Start: May 7, 2020
• Primary Completion: May 17, 2020
• Study Completion: May 31, 2020
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)