Repeated Dosing Clinical Trial to Assess the Pharmacokinetic Characteristics and Safety/Tolerability of HL151 Formulation in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetic characteristics of bepotastine after multiple oral administration of TALION tab., a IR formulation of bepotastine as reference drug and HL151, a SR formulation of bepotastine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male in the age of 19-45
- •Body weight ≥ 50kg, BMI 18~29 kg/m2
- •Subject who sign on an informed consent form willingly
排除标准
- •Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •Subject with acute disease within 28 days prior to study medication dosing
- •Subject with known for history of disease which affect on the absorption, distribution, metabolism, excretion of drug
- •Subject with clinically significant chronic disease
- •Positive on the test of HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL
- •Use of any prescription medication within 14 days prior to study medication dosing
- •Use of any medication such as over-the-counter medication including oriental medication within 7 days prior to study medication dosing
- •Subject with clinically significant allergic disease
- •Subject with known for hypersensitivity reaction to bepotastine
- •Subject with any of the following conditions in laboratory test
- •AST/ALT > UNL (upper normal limit) x 2
- •Total bilirubin > UNL x 2
- •Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)]
- •SBP<100mmHg or ≥160mmHg, DBP<60mmHg or ≥100mmHg
- •QTc>440msec on ECG
- •Serum potassium < 3.5 mEq/L or > 5.5 mEq/L
- •Immunological incompetence, immune deficiency or taking immunosuppressants
- •Subject who cannot take standard meal
- •Subject with whole blood donation within 60days, component blood donation within 20days prior to study medication dosing
- •Subject with blood transfusion within 30days prior to study medication dosing
- •Participation in any clinical investigation within 90days prior to study medication dosing
- •Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
- •Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
- •Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 30days prior to study medication dosing
- •Subject who are not using adequate means of contraception
- •Subject with genetic problems such as galactose intolerance, Lapp Lactase Deficiency or glucose-galactose malabsorption
- •Subject with history of drug abuse or drug addiction
研究组 & 干预措施
T-R
First period : administration of test drug Second period : administration of reference drug
干预措施: HL151 (Drug)
T-R
First period : administration of test drug Second period : administration of reference drug
干预措施: TALION tab. (Drug)
R-T
First period : administration of reference drug Second period : administration of test drug
干预措施: HL151 (Drug)
R-T
First period : administration of reference drug Second period : administration of test drug
干预措施: TALION tab. (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve during a dosing interval(AUCτ,ss)
时间窗: 24 hours after 4 days' repeated dosing
Maximum the plasma concentration during a dosing interval(Cmax,ss)
时间窗: 24 hours after 4 days' repeated dosing
次要结局
- Number of participants with adverse events(During 4 days' repeated dosing and post-study visit(within 5 days from discharge))