Bioequivalence Study Comparing Two Salmeterol/Fluticasone Propionate Dry Powder Inhalers, SF Easyhaler and Seretide Diskus 50/500 Mcg/Inhalation; Randomised, Double-blind, Single Centre, Single Dose, Crossover Study in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter Cmax of plasma salmeterol concentration
研究概览
简要总结
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 aged 18-60 years
- •Normal weight, at least 50 kg
排除标准
- •Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- •Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- •Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- •Known hypersensitivity to the active substance(s) or the excipient of the drug.
- •Pregnant or lactating females.
研究组 & 干预措施
SF Easyhaler and charcoal
Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal
干预措施: SF Easyhaler and charcoal (Drug)
Seretide Diskus and charcoal
Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal
干预措施: Seretide Diskus and charcoal (Drug)
Seretide Diskus
Single-dose of Seretide Diskus (50/500 mcg/inhalation)
干预措施: Seretide Diskus (Drug)
SF Easyhaler
Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation)
干预措施: SF Easyhaler (Drug)
结局指标
主要结局
Pharmacokinetic parameter Cmax of plasma salmeterol concentration
时间窗: Within 34 h
Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration
时间窗: Within 34 h
Pharmacokinetic parameter AUCt of plasma salmeterol concentration
时间窗: within 34 h
Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration
时间窗: within 34 h
次要结局
未报告次要终点