A Randomized, Single-Dose, Double-Blind, Double-Dummy, Four-Period, Four-Sequence, Four-Treatment, Placebo and Active Controlled, Comparative, Multiple-Center, Crossover-Design, Bronchoprovocation Study to Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg Base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (Albuterol Sulfate) Inhalation Aerosol, eq 90 mcg Base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 8
- 主要终点
- Pharmacodynamic Endpoint Post-dose PC20
研究概览
简要总结
To Evaluate the Pharmacodynamic Equivalence of Albuterol Sulfate Inhalation Aerosol, eq 90 mcg base (Sun Pharmaceuticals Industries Limited) to PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg base (Teva Respiratory, LLC) in Subjects With Stable, Mild Asthma
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or non-pregnant women 18 to 65 years of age.
- •Signed informed consent form that meets all criteria of current Food and Drug Administration (FDA) regulations.
- •Females of childbearing potential must not be pregnant or lactating (as confirmed by a negative urine pregnancy test
- •Ability to use inhalation aerosol correctly.
排除标准
- •Any clinically significant finding on physical exam in the opinion of the Investigator, would compromise subject's safety or data integrity.
- •Employees of the Investigator or research center or their immediate family members.
- •Previous participation in this study.
- •Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
研究组 & 干预措施
Test
Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
干预措施: Zero-dose (Drug)
Test
Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
干预措施: 90 mcg of PROAIR® HFA (Drug)
Test
Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
干预措施: 180 mcg of 90 mcg of PROAIR® HFA (Drug)
Test
Albuterol Sulfate Inhalation Aerosol, eq 90 mcg
干预措施: 90 mcg of albuterol sulfate inhalation aerosol (Drug)
Reference
PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
干预措施: Zero-dose (Drug)
Reference
PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
干预措施: 90 mcg of PROAIR® HFA (Drug)
Reference
PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
干预措施: 180 mcg of 90 mcg of PROAIR® HFA (Drug)
Reference
PROAIR® HFA (albuterol sulfate) Inhalation Aerosol, eq 90 mcg
干预措施: 90 mcg of albuterol sulfate inhalation aerosol (Drug)
Test Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
干预措施: Zero-dose (Drug)
Test Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
干预措施: 90 mcg of PROAIR® HFA (Drug)
Test Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
干预措施: 180 mcg of 90 mcg of PROAIR® HFA (Drug)
Test Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
干预措施: 90 mcg of albuterol sulfate inhalation aerosol (Drug)
Reference Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
干预措施: Zero-dose (Drug)
Reference Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
干预措施: 90 mcg of PROAIR® HFA (Drug)
Reference Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
干预措施: 180 mcg of 90 mcg of PROAIR® HFA (Drug)
Reference Placebo
Placebo for Albuterol Sulfate Inhalation Aerosol
干预措施: 90 mcg of albuterol sulfate inhalation aerosol (Drug)
结局指标
主要结局
Pharmacodynamic Endpoint Post-dose PC20
时间窗: Approximately 15 minutes after last inhalation of study product
The primary pharmacodynamic endpoint is the post-dose PC20, which is the provocative concentration of methacholine challenge agent required to reduce the forced expiry volume in one second (FEV1) by 20%, following the administration of different doses of albuterol (or placebo) by inhalation. Primary analysis group -pharmacodynamic population.
次要结局
未报告次要终点