Pharmacokinetic Formulation Feasibility Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Easyhaler Test Products and Reference Product Ultibro Breezhaler
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
- Peak indacaterol and glycopyrronium concentration in plasma (Cmax)
研究概览
简要总结
This is a formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhaler. The study treatments will be administered with concomitant oral charcoal to block absorption via gastrointestinal tract and to assess pulmonary absorption only.
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
盲法说明
Bioanalytical laboratory will be blinded with regard to the sequence of the product administration.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females
- •18-60 years of age
- •Body mass index 19-30 kg/m2
- •Weight at least 50 kg
- •Written informed consent obtained
排除标准
- •Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease
- •Any condition requiring regular concomitant treatment
- •Any clinically significant abnormal laboratory value, vital sign or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject
- •Known hypersensitivity to indacaterol or glycopyrronium
- •Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
- •Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration
研究组 & 干预措施
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant A
Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant A in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses).
干预措施: Indacaterol/glycopyrronium (Drug)
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant B
Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant B in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses).
干预措施: Indacaterol/glycopyrronium (Drug)
Indacaterol/glycopyrronium Easyhaler® 85/43 µg/dose, inhalation powder, product variant C
Each subject will receive a single dose of 2 inhaled doses from Indacaterol/glycopyrronium Easyhaler product variant C in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses).
干预措施: Indacaterol/glycopyrronium (Drug)
Ultibro® Breezhaler® 85/43 µg inhalation powder, hard capsule
Each subject will receive 2 capsules of Ultibro® Breezhaler® (=Indacaterol/glycopyrronium) as a single dose in one of the four periods (cross-over) with concomitant charcoal administration (Carbomix granules). The total dose is 170 µg of indacaterol and 86 µg glycopyrronium (delivered doses).
干预措施: Indacaterol/glycopyrronium (Drug)
结局指标
主要结局
Peak indacaterol and glycopyrronium concentration in plasma (Cmax)
时间窗: between 0-72 hours after dosing
Pharmacokinetic parameters of indacaterol and glycopyrronium
Area under the concentration-time curve from time zero to 72 hours (AUC72)
时间窗: between 0-72 hours after dosing
Pharmacokinetic parameters of indacaterol and glycopyrronium
次要结局
- Area under the concentration-time curve from time zero to 30 minutes (AUC30)(between 0-30 minutes after dosing)
- Time to reach peak indacaterol and glycopyrronium concentration in plasma (tmax)(between 0-72 hours after dosing)