NCT01213849已完成1 期
An Open-label, Randomised, 3-way Crossover Single Dose Study to Demonstrate Dose Proportionality of Fluticasone Furoate (FF) and Equivalence of Vilanterol (VI) When Administered as FF/VI Inhalation Powder From the Novel Dry Powder Inhaler in Healthy 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
- 24
- 试验地点
- 1
- 主要终点
- Vilanterol area under concentration-time curve (AUC)
研究概览
简要总结
The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel dry powder inhaler in healthy subjects.
详细描述
The study will be an open-label, randomised, 3-way cross-over single dose study in 24 healthy subjects to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) following single dose administration of FF/VI via the novel dry powder inhaler. In each of 3 treatment periods, subjects will receive 4 inhalations of 50/25 mcg, 100/25 mcg, 200/25 mcg FF/VI. Blood samples will be taken for pharmacokinetic analysis and safety (12-lead ECGs, clinical laboratory test, vital signs, adverse events) will be monitored following each dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <or= 1.5xULN
- •Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- •Male or female between 18 and 65 years of age inclusive.
- •A female subject is eligible to participate if she is of:
- •Non-child-bearing potential defined as post-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea.
- •Child-bearing potential and agrees to use one of the approved contraception methods until 16 weeks after the last dose.
- •Male subjects with female partners of child-bearing potential must agree to use one of the approved contraception methods until 16 weeks after the last dose.
- •Body Mass Index (BMI) within range 18.5-29.0 kg/m2 (inclusive).
- •Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Average QTcF < 450 msec.
- •No clinically significant abnormality on the Holter electrocardiogram (ECG) at screening.
- •Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of < or = 5 pack years.
- •Able to satisfactorily use the dry powder inhaler.
排除标准
- •As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
- •The subject has a history of breathing problems in adult life (e.g. history of asthmatic symptomatology). Screening lung function tests (forced expiratory volume in 1 minute (FEV1)) will be performed to confirm normal lung function parameters (>or=85% predicted).
- •Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
- •Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- •The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
- •A positive HIV antibody.
- •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- •History of heavy regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units for males or >14 units for females.
- •History or regular use of tobacco- or nicotine-containing products within 12 months prior to screening.
- •Positive carbon monoxide or alcohol breath test at screening or on admission to the unit.
- •A positive pre-study urine drug screen or when randomly tested during the study.
- •The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- •Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- •Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- •The subject has taken systemic, oral or depot corticosteroids less than 12 weeks before the screening visit.
- •The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
- •History of sensitivity or adverse reaction to any of the study medications including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or an intranasal, inhaled or systemic corticosteroid; known suspected sensitivity to the constituents of the new powder inhaler (lactose or magnesium stearate) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation.
- •History of severe milk protein allergy.
- •Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months of the start of the study.
- •Pregnant females as determined by positive serum hCG test at screening or by positive serum/urine hCG test prior to dosing.
- •Lactating females.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •Subject is mentally or legally incapacitated.
- •Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
研究组 & 干预措施
200/100 mcg fluticasone furoate/vilanterol
Experimental
4 inhalations of 50/25 mcg fluticasone furoate/vilanterol
干预措施: Fluticasone furoate 50 mcg (4 inhalations) (Drug)
200/100 mcg fluticasone furoate/vilanterol
Experimental
4 inhalations of 50/25 mcg fluticasone furoate/vilanterol
干预措施: Vilanterol 25 mcg (4 inhalations) (Drug)
400/100 mcg fluticasone furoate/vilanterol
Experimental
4 inhalations of 100/25 mcg fluticasone furoate/vilanterol
干预措施: Fluticasone furoate 100 mcg (4 inhalations) (Drug)
400/100 mcg fluticasone furoate/vilanterol
Experimental
4 inhalations of 100/25 mcg fluticasone furoate/vilanterol
干预措施: Vilanterol 25 mcg (4 inhalations) (Drug)
800/100 mcg fluticasone furoate/vilanterol
Experimental
4 inhalations of 200/25 mcg fluticasone furoate/vilanterol
干预措施: Fluticasone furoate 200 mcg (4 inhalations) (Drug)
结局指标
主要结局
Vilanterol area under concentration-time curve (AUC)
时间窗: 48 hours post-dose
Fluticasone furoate area under concentration-time curve (AUC)
时间窗: 48 hours post-dose
Vilanterol maximum observed concentration (Cmax)
时间窗: 48 hours post-dose
Fluticasone furoate maximum observed concentration (Cmax)
时间窗: 48 hours post-dose
次要结局
- Vilanterol time of occurence of maximum concentration (tmax)(48 hours post-dose)
- Fluticasone furoate time of occurence of maximum concentration (tmax)(48 hours post-dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary DiseaseChronic Obstructive Pulmonary DiseaseNCT00403286Dey457
已完成
1 期
A Double Blind Open Label Comparator Study to Compare Treatments in 4 to 11 Year Old Patients With AsthmaAsthmaNCT02680561Teva Branded Pharmaceutical Products R&D, Inc.20
已完成
3 期
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With AsthmaAsthmaNCT02502734GlaxoSmithKline60
已完成
1 期
A Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate Inhalation Powder Administered by Novel Dry Powder Inhaler (NDPI)AsthmaNCT01669070GlaxoSmithKline36
已完成
1 期
Bioequivalence Study to Compare Fluticasone Furoate (FF) 1-strip Inhaler With FF 2-strip Inhaler and With FF/Vilanterol CombinationAsthmaNCT01485445GlaxoSmithKline30