Nebulizer Delivery of Intranasal Scopolamine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Time to maximal concentration for scopolamine after intranasal administration (Tmax)
研究概览
简要总结
To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.
详细描述
An aqueous scopolamine formulation is being administered via a nebulizer and the pharmacokinetics of the drug are being measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Adults age 21-49
- •Normal weight for body size, based on BMI table
- •General good health, as determined by a verbally provided medical history
- •Normal brief neurological exam
- •Renal and hepatic function within normal ranges
- •Able to provide written informed consent to participate
排除标准
- •Drug allergies to scopolamine or other belladonna alkaloid
- •Use of medications within 1 week of starting the study
- •Use of an investigational drug within 30 days of starting the study
- •Tobacco smoking within the past year
- •Blood donation or significant blood loss within 30 days of starting the study
- •Significant gastrointestinal disorder (e.g. Crohn's Disease, ulcerative colitis, chronic constipation), asthma, glaucoma, prostate problems, urinary obstruction, or seizure disorders
- •History of alcohol or other drug abuse
- •Pregnancy or suspected pregnancy, or lactation (pregnancy will be confirmed with urine pregnancy testing prior to drug administration)
- •Consumption of grapefruit juice within 7 days of scopolamine (SCOP) administration
- •Nasal, nasal sinus, or nasal mucosa surgery within 90 days prior to study initiation
- •Other significant surgeries within 90 days
- •Significant deviated septum that blocks air flow in one nostril
- •Rhinitis, sinus infection, severe allergies, and other upper respiratory infections within 30 days prior to the study
- •Current use of an intranasal medication
- •Wheezing or other respiratory problem
- •Unable to consent
研究组 & 干预措施
Pharmacokinetic
Participants receive 1 dose of Scopolamine 0.4 mg delivered via a intranasal nebulizer developed by Creare LLC.
干预措施: Scopolamine (Drug)
Chair
Participants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized.
干预措施: Scopolamine (Drug)
Chair
Participants receive 1 dose of Scopolamine 0.2 mg, 1 dose of Scopolamine 0.4 mg, and 1 dose of placebo saline delivered via the Creare LLC intranasal nebulizer. These dosages are all 1 week apart and the order is randomized.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to maximal concentration for scopolamine after intranasal administration (Tmax)
时间窗: Baseline, 180 minutes
Plasma scopolamine concentrations will be measured using an liquid chromatography-mass spectrometry (LC- MS) assay. Tmax is measured in minutes to reach the maximum concentration.
Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale
时间窗: 180 minutes
A questionnaire will be administered asking about the participant's side effect profile after taking intranasal scopolamine. The questionnaire will have a subjective rating scale of 0-10 on the potential scopolamine side effects expected
次要结局
- Effectiveness in reducing motion sickness as measured by duration of chair ride.(Baseline, end of chair ride (maximum of 20 minutes))
研究者
Jay C. Buckey Jr.
Professor of Medicine
Dartmouth-Hitchcock Medical Center