Status:
COMPLETED
An in Vivo Bioequivalence Study of 2 Loxoprofen Sodium Products in Vietnamese Healthy Male Volunteers
Lead Sponsor:
Centre of Clinical Pharmacology, Hanoi Medical University
Conditions:
Bioequivalence
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 pharmaco...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04386122
Start Date
May 7 2020
End Date
May 31 2020
Last Update
March 18 2021
Active Locations (1)
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1
Centre of Clinical Pharmacology, Hanoi Medical University
Hanoi, Vietnam