NCT01902121已完成1 期
A Phase 1, Open-label, Randomized, Crossover Clinical Trial in Healthy Normal Volunteers to Evaluate the Bioequivalence of 30 U TI Inhalation Powder Delivered by Gen2 Inhaler Using One 30 U Cartridge Versus a Combination of 10 U and 20 U Cartridges
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
- 40
- 主要终点
- Area-under-the-serum insulin concentration versus time curve (AUC0-240min
研究概览
简要总结
A Phase 1, open-label, randomized, crossover study in 36 healthy normal volunteers (HNVs) to evaluate the bioequivalence of TI Inhalation Powder delivered using the Gen2 Inhaler and administered as one 30 U cartridge versus a combination of one 10 U cartridge and one 20 U cartridge.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis
- •No smoking in the past 6 months (including cigarettes, cigars, and pipes)
- •Urine cotinine testing < 100 ng/mL
- •Body mass index < 32 kg/m2
- •Completion of informed consent form
排除标准
- •FBG > 100 mg/dL
- •Clinically significant active or chronic illness
- •History of asthma, chronic obstructive pulmonary disease (COPD), or any other clinically relevant chronic lung disease
- •Respiratory tract infection within 4 weeks before screening and between the screening visit and dosing visit
- •Subjects who are experiencing persistent or recurring cough, wheezing, bronchospasm, or dyspnea
研究组 & 干预措施
TI 30 units (10 unit + 20 unit
Experimental
Technosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge
干预措施: Technosphere® Insulin 10U + 20U (Drug)
TI 30 units (30 unit cartridge
Experimental
Technosphere® Insulin 30 units given as one 30 unit cartridge
干预措施: Technosphere® Insulin 30U (Drug)
结局指标
主要结局
Area-under-the-serum insulin concentration versus time curve (AUC0-240min
时间窗: 0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing
次要结局
未报告次要终点
研究者
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