Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers
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.
Focus of Study: Absorption of the Three Components in the Topical ABH Gel in Healthy Volunteers, and Determine if There Are Any Adverse Effects.
Drug: diphenhydramine hydrochloride
Other: questionnaire administration
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers|
- Lorazepam, Diphenyhydramine, Haloperidol Absorption [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Level of lorazepam absorption measured by the serum concentration of the drug
- Side Effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Experimental: Arm I
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Other Name: AtivanDrug: diphenhydramine hydrochloride
Other Names:Drug: haloperidol
Other Names:Other: questionnaire administration
Ancillary studiesOther: laboratory biomarker analysis
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.
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Thomas Smith||Virginia Commonwealth University|