NCT00414778已完成1 期
A Single-center, Open-label, Single and Multiple Oral Dose Study to Assess Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects
研究概览
简要总结
The purpose of this study is to evaluate safety and pharmacokinetics of a single and multiple dose of LHT344 in 12 Chinese healthy subjects.
This study is not recruiting subjects in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-smoking, male or female subjects age 18 to 45 years of age
- •In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
- •Body mass index within the range of 19 to 24 kg/m2 and weigh at least 50 kg
排除标准
- •Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.
- •Participation in any clinical investigation within 3 months prior to dosing.
- •Donation or loss of 400 mL or more of blood within 12 weeks prior to first dosing required by local regulation.
- •Significant illness within 2 weeks prior to dosing.
- •A past personal or close family medical history of clinically significant cardiac abnormalities such as a myocardial infarction, angina, arterial fibrillation, arrhythmia or hypertension.
- •History of
- •fainting, low blood pressure upon standing, irregular heart beats
- •acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- •clinically significant drug allergy, history or presence of atopic allergy (asthma, urticaria, eczematous dermatitis)
- •known hypersensitivity to the study drug or similar drugs
- •surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or may jeopardize the subject participation in the study
- •immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- •positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •drug or alcohol abuse within the 12 months prior to study participation
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Pharmacokinetics of single and repeat daily oral dose of LHT344 in Chinese healthy subjects
次要结局
- Safety of single and repeat daily oral dose of LHT344 in Chinese healthy subjects
研究者
研究点 (1)
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