Phase I Single Blind, Randomised, Cross-over Pharmacodynamic Dose Response Study in Healthy Volunteers of Two Pressurized Metered Dose Inhalers (pMDIs) That Deliver Salmeterol and Fluticasone Propionate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Relative Potency QTcB Interval
研究概览
简要总结
The purpose of this study is to test the body's response to several doses of two different inhalation products in healthy volunteers.
详细描述
Healthy subjects will be enrolled and will receive 2, 6, and 12 inhalations from both the test and reference pMDI products according to a six-period cross-over design. Electrocardiograms (ECGs) and plasma potassium and glucose levels will be measured pre-dose and over 6 hours post-dose.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteer
- •Willing and able to give informed consent
- •Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
- •Male and female subjects aged 18 to 55 years (inclusive)
- •Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration
排除标准
- •Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
- •Any presence or history of a clinically significant allergy including any adverse reaction to study drug
- •History of drug or alcohol abuse within the past 2 years
- •Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
- •Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
- •Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
- •If female, nursing, lactating or pregnant
- •Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- •Surgery scheduled during the study or within 3 weeks after last dose
- •History of familial long QT syndrome or history of sudden death in family members aged < 30 years
研究组 & 干预措施
test product C
salmeterol and fluticasone propionate, 12 puffs
干预措施: fluticasone propionate (Drug)
test product A
salmeterol and fluticasone propionate, 2 puffs
干预措施: Salmeterol (Drug)
test product A
salmeterol and fluticasone propionate, 2 puffs
干预措施: fluticasone propionate (Drug)
reference product D
salmeterol and fluticasone propionate, 2 puffs
干预措施: Salmeterol (Drug)
reference product D
salmeterol and fluticasone propionate, 2 puffs
干预措施: fluticasone propionate (Drug)
test product B
salmeterol and fluticasone propionate, 6 puffs
干预措施: Salmeterol (Drug)
test product B
salmeterol and fluticasone propionate, 6 puffs
干预措施: fluticasone propionate (Drug)
reference product E
salmeterol and fluticasone propionate, 6 puffs
干预措施: Salmeterol (Drug)
reference product E
salmeterol and fluticasone propionate, 6 puffs
干预措施: fluticasone propionate (Drug)
test product C
salmeterol and fluticasone propionate, 12 puffs
干预措施: Salmeterol (Drug)
reference product F
salmeterol and fluticasone propionate, 12 puffs
干预措施: Salmeterol (Drug)
reference product F
salmeterol and fluticasone propionate, 12 puffs
干预措施: fluticasone propionate (Drug)
结局指标
主要结局
Relative Potency QTcB Interval
时间窗: Baseline up to 6 hrs
Selection of steepest part of dose response curve for Relative Potency: 2 and 6 inhalation dose pairs. Slope of A and B line compared with slope of D and E to obtain relative potency value. Twelve inhalation dose not utilized as not on steepest part of curve.
Relative Potency Max Heart Rate
时间窗: Baseline, up to 6 hrs
Selection of steepest part of dose response curve for Relative Potency: 6 and 12 inhalation dose pairs. Slope of B and C line compared with slope of E and F to obtain relative potency value. Two inhalation dose not utilized as not on steepest part of curve.
次要结局
- Max Heart Rate(Baseline through 6 hours)
- Plasma Potassium Level(baseline through 6 hours)
- Max Plasma Glucose Level(baseline through 6 hours)
- Max QTcB(Baseline through 6 hours)