CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS, A Randomized, Evaluator-Blind, Single-Dose, Three Arm, Crossover,PK Study in Healthy Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Pharmacokinetics including maximum concentration and area under the curve
研究概览
简要总结
This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the administered drug from the endogenous epinephrine, in healthy male and female adult volunteers.
详细描述
The current study is designed to complement and expand the previous PK studies, API-E004-CL-B and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also be evaluated, under augmented dose conditions.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy at screening;
- •Body weight ≥ 50 kg for men and ≥ 45 kg for women;
- •Sitting blood pressure ≤ 135/90 mmHg;
- •Demonstrating negative hIV, HBsAG and DCV-Ab screen tests;
- •Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
- •Properly consented
- •Other criteria apply
排除标准
- •A smoking history of ≥10 pack-years, or having smoked within 6 months prior to Screening;
- •Upper respiratory tract infections within 2 wk, or lower respiratory tract infection within 4 wk, prior to Screening;
- •Any current or recent respiratory conditions that might significantly affect pharmacodynamic response to the study drugs;
- •Known intolerance or hypersensitivity to the study MDI ingredients;
- •Having been on other investigational drug/device studies, or donated blood, in the last 30 days prior to Screening;
- •Other criteria apply
结局指标
主要结局
Pharmacokinetics including maximum concentration and area under the curve
时间窗: -30, 2, 5, 7.5, 10, 12.5, 15, 20, 25, 30, 45, 60, 90, 120, 240 and 360 min postdose.
Samples will be analyzed with an established LC/MS/MS method, with a quantitative detection limit of 0.02 ng/mL, for both epinephrine-d3 and epinephrine-h3. * Mean Maximum concentration of epinephrine (Cmax for epinephrine) * Mean Area Under the Curve (AUC) for epinephrine * Time to maximum concentration (tmax) and Half life of the drug (t1/2) * Epinephrine concentrations versus time
次要结局
- Vital Signs(within 30 min predose, at 30, 60 and 360 min postdose)
- 12-lead Electrocardiogram (ECG)(within 30 min pre-dose, and at 15 and 120 min post-dose)
- Telemetry ECG(within 30 min pre-dose, and during the initial 5 min post-dose)