NCT01953367已完成1 期
Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions 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
- 72
- 试验地点
- 1
- 主要终点
- To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects
研究概览
简要总结
This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.
Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy subjects of any ethnic origin
- •Aged between 18 and 50 years of age
- •Body weight of ≥50 kg and body mass index (BMI) between 18.5 and 29 kg/m2
- •FEV1 > 90% of predicted
- •Able to demonstrate correct inhaler use
- •Written informed consent
排除标准
- •History of clinically relevant allergies or idiosyncrasies to tobramycin or any other inactive ingredient(s) of the IMP
- •Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis.
- •Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric or other diseases at screening
- •Surgery of the gastrointestinal or respiratory tract which might interfere with drug absorption
- •History of malignancy within the past 5 years
- •History of orthostatic hypotension, faintings or blackouts
- •Acute or chronic viral, bacterial or fungal airway infections, including laryngeal infections, mouth and throat infections, and hoarseness;
- •Other clinically relevant chronic or acute infectious illnesses
- •Clinical chemical, hematological or any other laboratory parameters clinically relevant outside the normal range
研究组 & 干预措施
Vantobra; Treatment A
Experimental
Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution
干预措施: Vantobra (tobramycin) (Drug)
TOBI; Treatment B
Active Comparator
TOBI, 300 mg tobramycin/5 mL nebulizer solution
干预措施: TOBI (tobramycin) (Drug)
结局指标
主要结局
To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects
时间窗: Day 1 and Day 7
tmax of tobramycin
次要结局
- Number of Adverse Events during the trial period(Adverse Events during the study period of max. 17 days)
研究者
研究点 (1)
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