NCT01280175已完成1 期
Pharmacokinetics and Lung Bioavailability of BDP/Formoterol HFA Fixed Combination After Single Administration in 12 Healthy Volunteers Using the Standard Actuator With or Without Charcoal Block or the Aerochamber Spacer.
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
- 13
- 试验地点
- 1
- 主要终点
- Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.
研究概览
简要总结
The purpose of this study is to evaluate the systemic exposure of BDP, its metabolite beclomethasone 17-monopropionate (B17MP) and formoterol after inhalation of BDP/Formoterol 100/6 µg pMDI combination (CHF1535) using the standard actuator and charcoal block technique or using a Spacer (AeroChamber Plus, Trudell) in comparison with inhalation using the standard actuator
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
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Sex: male
- •18≤age≤45 years old
- •BMI: 18≤BMI≤28 kg/m2
- •Non-smokers
- •Vital signs: SBP 100-139 mmHg, DBP 50-89, HR 50-90 bpm, measured after 5 min of rest in the sitting position
- •Full comprehension: ability to use correctly the pMDI preparations; ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study
- •Informed Consent: signed written informed consent prior to inclusion in the study.
排除标准
- •ECG (12 leads): clinically relevant abnormalities and/or QTc >450 msec;
- •Physical findings: clinically relevant abnormal physical findings, which could interfere with the objectives of the study; in particular any abnormality in the lung functionality: FEV1 <80% predicted values according to European Respiratory Society basing upon Quanjer et al. (25)
- •Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness; in particular positive HIV1 and HIV2 serology and/or positive hepatitis serology indicating acute or chronic hepatitis B or C
- •Allergy: ascertained or presumptive hypersensitivity to the active principles and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- •Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study
- •Medications: medication, including OTC, during 2 weeks before the start of the study. Any known enzyme inducing drug or enzyme inhibitor must be stopped at least 2 months before study start
- •Investigative drug trials: participation in the evaluation of any drug within 3 months prior to the screening
- •Blood donation: blood donations during the 3 months prior to this study
- •Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>2 drinks/day, defined according to USDA Dietary Guidelines 2005 (26)], caffeine (>5 cups coffee/tea/day) abuse or smoking
- •Abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits within the past 4 weeks.
研究组 & 干预措施
pMDI + Aerochamber Plus
Experimental
BDP/formoterol 100/6 µg with Aerochamber Plus
干预措施: Aerochamber Plus spacer (Device)
pMDI + charcoal block
Experimental
BDP/formoterol 100/6 µg pMDI with charcoal ingestion
干预措施: charcoal block (Procedure)
pMDI
Active Comparator
BDP/formoterol 100/g µg pMDI
干预措施: pMDI standard actuator (Drug)
结局指标
主要结局
Systemic exposure and lung bioavailability of BDP, B17MP and formoterol.
时间窗: from pre-dose until 12 h post-dose
次要结局
- General tolerability and safety of the test product.(from pre-dose until 12 h post-dose)
研究者
研究点 (1)
Loading locations...
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