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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Bioequivalence

Intervention / Treatment
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* Drug: FABALOFEN 60
* Drug: JAPROLOX TABLET


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized, single-dose, 2-sequence, 2-period, 2-treatment crossover study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FABALOFEN 60<br>Subjects will receive a single dose of 1 FABALOFEN 60 tablet under fed condition | Drug: FABALOFEN 60<br>* 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<br>* Other names: Loxoprofen sodium 60mg/tablet;|
| Active Comparator: JAPROLOX TABLET<br>Subjects will receive a single dose of 1 JAPROLOX® TABLETS tablet under fed condition | Drug: JAPROLOX TABLET<br>* 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<br>* Other names: Loxoprofen sodium 60mg/tablet;|

What is the study measuring?
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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 |