NCT01925313已完成1 期
A Randomized, Open Label, Three-Treatment, Three-Period, Six-Sequence Crossover Study To Compare Safety and Pharmacokinetic Properties of CJ-30044 and Bepotastine Besilate and To Investigate Food-effect on Pharmacokinetics of CJ-30044 in Healthy Adult Male Volunteers
适应症
干预措施
相关药物
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
- AUClast and Peak plasma concentration (Cmax) of Bepotastine
研究概览
简要总结
Study objectives
- To compare the safety and pharmacokinetic properties of CJ-30044 and bepotastine besylate after a single oral administration in healthy male volunteers.
- To evaluate the food-effect on pharmacokinetics of CJ-30044 after a single oral administration in healthy male volunteers.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male volunteers in the age between 20 and 45 years old
- •BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
- •Subject with no history of any significant chronic disease
- •Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators
- •Willing to adhere to protocol requirements and sign a informed consent form
排除标准
- •History of clinically significant allergies, including Bepotastine.
- •History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
- •History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
- •Subjects considered as unsuitable health on the basis of their vital sign, ECG, physical exam and routine laboratory data for this trial by investigators.
- •Clinical laboratory test values are outside the accepted normal range
- •AST or ALT >1.25 times to normal range
- •Total bilirubin >1.5 times to normal range
- •Estimated GFR(Glomerular Filtration Rate) < 80 mL/min/1.73m2
- •Clinically significant vital sign
- •SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
- •DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
- •History of drug abuse or positive urine screen for drugs
- •History of caffeine, alcohol, smoking abuse
- •caffeine > 5 cups/day
- •alcohol > 210g/week
- •smoking > 10 cigarettes/day
- •Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
- •Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
- •Participated in a previous clinical trial within 60 days prior to dosing
- •Donated blood within 60 days prior to dosing
- •Subjects considered as unsuitable based on medical judgement by investigators
研究组 & 干预措施
CJ-30044
Experimental
干预措施: CJ-30044 (Drug)
TALION TAB. 10mg
Active Comparator
干预措施: TALION TAB. 10mg (Drug)
结局指标
主要结局
AUClast and Peak plasma concentration (Cmax) of Bepotastine
时间窗: Blood sampling up to 36hs post dose.
次要结局
- AUCinf, Tmax, T1/2 of Bepotastine(Blood sampleing up to 36hrs post dose)
研究者
研究点 (1)
Loading locations...
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