NCT00947596已完成1 期
Development of an Inhaled, Dry Powder Delivery System for the Administration of Atropine Sulfate
MicroDose Defense Products L.L.C.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector)
研究概览
简要总结
MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by the ADPI to atropine delivery from the AtroPen autoinjector.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be 18-55 years of age.
- •Subjects will be able to read and comprehend the English language.
排除标准
- •Subjects weighing less than 100 lbs.
- •Women of childbearing potential who are pregnant or unwilling to undergo pregnancy testing; females with positive pregnancy testing on either screening day or any test day will be excluded. Nursing mothers will be excluded
- •Persons unable or unwilling to complete written informed consent (No proxy consent will be obtained).
- •Persons with a past medical history or symptoms of pulmonary disease (including but not limited to: asthma, COPD, Emphysema, Sarcoidosis, Lung Cancer, Pulmonary Embolism, Pulmonary Hypertension))or cardiac disease (coronary artery disease, hypertension, angina, arrhythmias, palpitations, past myocardial infarction history).
- •Persons with a previous history or symptoms of adverse reaction to atropine.
- •Persons with history or symptoms of prostate hypertrophy or prostate cancer.
- •Persons with a history or symptoms of pyloric stenosis.
- •Persons with a history or symptoms of high blood pressure or a diagnosis of cerebral vascular accident (CVA) or transient ischemic attack (TIA).
- •Subjects with a history or symptoms of urological disorders or renal insufficiency.
- •Subjects with a history or symptoms of diabetes.
- •Persons demonstrating increased intraocular pressure, an abnormal optical exam, or history of glaucoma.
- •Persons demonstrating a one second forced expiratory volume (FEV1) or a forced vital capacity (FVC) of less than 70% of predicted either at screening or during pre test exam will be excluded
- •Persons demonstrating any kind of irregular heart rhythm during pre test screening will be excluded. Persons demonstrating any irregular rhythms during testing will be immediately removed.
- •from testing and receive appropriate care and referral from the study physician
- •Persons will be excluded if any two laboratory tests characterizing a specific organ system are more than 10% outside of normal range
- •Subjects with screening day vital signs considered to be beyond normal range will be excluded. This will include BP systolic > 140, Diastolic > 90, HR > 100, RR > 20, temp >
- •The study physician will have the discretion to exclude subjects that he/she feels will not be able to safely able to participate in these studies based on review of all screening materials.
- •Self reported tobacco use or positive cotinine testing.
- •Any individuals with positive results on a urine drug screening will be excluded.
- •Persons with an O2 saturation value < 92%.
- •Persons who have performed other medical studies involving drug delivery in the last 30 days.
- •Blood donation in the last 30 days.
- •Subjects regularly utilizing any of the following medications will be excluded: amantadine, quinidine, phenothiazines, tricyclic antidepressants, digoxin, potassium chloride and potassium citrate formulations, topiramate, zonisamide.
- •Subjects under 18 years of age.
研究组 & 干预措施
Atropine Dry Powder Inhaler
Experimental
干预措施: atropine sulfate (Drug)
Atropen Autoinjector
Active Comparator
干预措施: atropine sulfate (Drug)
结局指标
主要结局
To characterize pharmacokinetic endpoints for atropine dry powder inhalation (Cmax, Tmax, AUC) and compare these to intramuscular pharmacokinetics (Atropen autoinjector)
时间窗: Multiple plasma samples collected up to 12 hours post dose
次要结局
- To evaluate the safety and tolerability of atropine dry powder inhalation (Clinical Labs testing, Pulse, Pulse Oximetry, Temperature, Heart Rate, Pulmonary Function Tests, Respiratory Rate, Near Point of Accommodation, Pupil Size).(up to 36 days (including 14 day screening period))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316AsthmaNCT02041221Sun Pharma Advanced Research Company Limited64
已完成
1 期
Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable AspirinPlatelet Aggregation InhibitorsNCT04328883Inova Health Care Services19
已完成
1 期
A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler DeviceHealthyBronchiectasisNCT00730977Syntara15
已完成
4 期
Teva Asthma Predictive Analytics StudyAsthmaNCT04997304University of Michigan100
已完成
2 期
A Dose-ranging Study to Evaluate Albuterol and Hydrofluoroalkane in Subjects Ages 12 and Older With Persistent AsthmaAsthmaNCT01058863Teva Branded Pharmaceutical Products R&D, Inc.72