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

March 17, 2021 updated by: Centre of Clinical Pharmacology, Hanoi Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC0-t
Time Frame: Up to 8 hours post-administration
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
Time Frame: Up to 8 hours post-administration
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 Frame: Up to 8 hours post-administration
Time until Cmax is reached. Tmax is analyzed with Wilcoxon non-parametric test
Up to 8 hours post-administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to approximately 14 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre of Clinical Pharmacology, Hanoi Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thanh P Nguyen, MD, Centre of Clinical Pharmacology, Hanoi Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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