NL-OMON53462已完成不适用
A single dose two-way cross-over study in healthy participants to compare the pharmacokinetics (PK) of salbutamol administered via metered dose inhalers containing propellants HFA-152a and HFA 134a - Green (Sustainable) Ventolin - PK study in healthy volunteers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1.Sex: male or female; females may be of childbearing potential, of
- •nonchildbearing potential, or postmenopausal
- •2. Age : 18 to 50 years, inclusive, at screening
- •3. BMI : 18.0 to 30.0 kg/m2, inclusive, at screening
- •4. Weight : >=50 kg
- •5. Status : healthy participants
- •Further criteria apply
排除标准
- •1. History or presence of cardiovascular, respiratory, hepatic, renal,
- •gastrointestinal, endocrine, hematologic, or neurological disorders capable of
- •significantly altering the absorption, metabolism, or elimination of drugs;
- •constituting a risk when taking the study intervention or interfering with the
- •interpretation of data.
- •2. History or presence of any form of asthma, including childhood asthma and
- •exercise induced asthma.
- •3. Systolic blood pressure <90 mmHg or >140 mmHg, or diastolic blood pressure
- •<50 mmHg or >90 mmHg.
- •4. History of pathological tachycardia, or a pulse rate > 85 bpm at screening
- •or Day -1.
- •5. Lymphoma, leukemia, or any malignancy within the past 5 years except for
- •basal cell or squamous epithelial carcinomas of the skin that have been
- •resected with no evidence of metastatic disease for 3 years.
- •Further criteria apply
研究者
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