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

Jeil Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 31 人2017年7月6日

适应症Smoking, Cigarette

干预措施Champix®Zeropix

概览

阶段: 1 期
干预措施: Champix®
疾病 / 适应症: Smoking, Cigarette
发起方: Jeil Pharmaceutical Co., Ltd.
入组人数: 31
试验地点: 1
主要终点: AUCt of Varenicline
状态: 已完成
最后更新: 8年前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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

注册库

clinicaltrials.gov

开始日期

2017年7月6日

结束日期

2017年9月8日

最后更新

8年前

研究类型

Interventional

研究设计

Crossover

性别

Male

研究者

发起方

Jeil Pharmaceutical Co., Ltd.

责任方

Sponsor

入排标准

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