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

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.

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.