Bioequivalence
Conditions
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.
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.
Interventions
DRUGFABALOFEN 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
DRUGJAPROLOX 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
Sponsors
Centre of Clinical Pharmacology, Hanoi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized, single-dose, 2-sequence, 2-period, 2-treatment crossover study
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-t | 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. |
| Cmax | 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. |
| Tmax | Up to 8 hours post-administration | Time until Cmax is reached. Tmax is analyzed with Wilcoxon non-parametric test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 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) |
Countries
Vietnam
Outcome results
None listed