NCT03362008已完成1 期
A Randomized, Open-label, 2-Way, 2-Period, Single-Dose Crossover Clinical Study to Compare the Pharmacokinetic Characteristics and the Safety Between Zeropix Tablet 1 mg and Champix® Tablet 1 mg in Healthy Adult Male Subjects
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
- 31
- 试验地点
- 1
- 主要终点
- AUCt of Varenicline
研究概览
简要总结
This study is a randomized, open-label, 2-way, 2-period, single-dose crossover clinical study to compare the pharmacokinetic characteristics and the safety between zeropix tablet 1 mg and champix® tablet 1 mg in healthy adult male subjects
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 older than 19 to 45 years at the time of screening
- •Body weight more than 50kg and Body Mass Index(BMI) 18~29 kg/m2 ☞ BMI = (weight [kg])/(height [m])2
- •Subject judged to be eligible by physical examination and interview conducted according to the study protocol. Thus, Subject should not have congenital/chronic disease or pathological symptoms/findings
排除标准
- •Subject currently with or has a history of cardiovascular , respiratory, hepatic, renal, neurological, endocrine, hemato-oncology, psychiatric, urinary diseases that is clinically significant
- •Subject with a history of significant hypersensitivity or clinically significant hypersensitivity reaction to varenicline and other drugs (aspirin, antibiotic...etc.)
- •Systolic blood pressure ⩽100mmHg or ⩾ 150mmHg, diastolic blood pressure⩽55mmHg or ⩾ 95mmHg
- •Subject with a history of gastrointestinal disease (i.e. Crohn's disease, ulcer...etc.) or gastrointestinal surgery (not including, simple appendectomy or hernia surgery) that can affect drug absorption
- •Subject with the following results in the clinical laboratory tests
- •Aspartate Transaminase(AST) or Alanine Transaminase(ALT) > 2 x upper limit of normal range
- •Total Bilirubin > 2.0 mg/dl
- •CK > 2 x upper limit of normal range
- •eGFR < 60 mL/min/1.73m2
- •Subject who takes alcohol > 21 units/week, 1unit=10g=12.5ml of pure alcohol) or can't stop drinking during the clinical trials
- •Subject who smokes> 10 cigarettes/day or can't stop smoking during the clinical trials
研究组 & 干预措施
Group I
Experimental
Period I: administration of Zeropix Period II: administration of Champix®
干预措施: Champix® (Drug)
Group I
Experimental
Period I: administration of Zeropix Period II: administration of Champix®
干预措施: Zeropix (Drug)
Group II
Experimental
Period I: administration of Champix® Period II: administration of Zeropix
干预措施: Zeropix (Drug)
Group II
Experimental
Period I: administration of Champix® Period II: administration of Zeropix
干预措施: Champix® (Drug)
结局指标
主要结局
AUCt of Varenicline
时间窗: 96 hours
Cmax of Varenicline
时间窗: 96 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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