Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Lorazepam, Diphenyhydramine, Haloperidol Absorption
研究概览
简要总结
RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.
详细描述
OBJECTIVES:I. To study the absorption of the three components in the topical ABH gel in 10 healthy volunteers, and determine if there are any adverse effects. OUTLINE: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. After completion of study treatment, patients are followed up for 5 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completed a medical screening questionnaire
- •English speaking
- •No allergies to the drugs
- •Able to complete the forms
- •If a woman of childbearing age, agree to use contraception
排除标准
- •History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age)
- •Use of any medication that would contraindicate benzodiazepine administration
- •Pregnant or nursing
研究组 & 干预措施
Arm I
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
干预措施: lorazepam (Drug)
Arm I
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
干预措施: diphenhydramine hydrochloride (Drug)
Arm I
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
干预措施: haloperidol (Drug)
Arm I
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
干预措施: questionnaire administration (Other)
Arm I
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Lorazepam, Diphenyhydramine, Haloperidol Absorption
时间窗: 4 hours
Level of lorazepam absorption measured by the serum concentration of the drug
次要结局
- Side Effects(3 months)