Clinical trial NCT04386122: An in Vivo Bioequivalence Study of 2 Loxoprofen Sodium Products in Vietnamese Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalence
Lead sponsor: Centre of Clinical Pharmacology, Hanoi Medical University
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, single-dose, 2-sequence, 2-period, 2-treatment crossover study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AUC0-t
timeFrame: Up to 8 hours post-administration
measure: Cmax
timeFrame: Up to 8 hours post-administration
measure: Tmax
timeFrame: Up to 8 hours post-administration
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to approximately 14 days
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Centre of Clinical Pharmacology, Hanoi Medical University
Study officials:
affiliation: Centre of Clinical Pharmacology, Hanoi Medical University
name: Thanh P Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: