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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
FABALOFEN 60
Subjects will receive a single dose of 1 FABALOFEN 60 tablet under fed condition
干预措施: FABALOFEN 60 (Drug)
JAPROLOX TABLET
Subjects will receive a single dose of 1 JAPROLOX® TABLETS tablet under fed condition
干预措施: JAPROLOX TABLET (Drug)
结局指标
主要结局
AUC0-t
时间窗: 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.
Tmax
时间窗: Up to 8 hours post-administration
Time until Cmax is reached. Tmax is analyzed with Wilcoxon non-parametric test
Cmax
时间窗: 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.
次要结局
- Adverse Events(Up to approximately 14 days)