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Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers


N/A
18 Years
N/A
Not Enrolling
Both
Focus of Study: Absorption of the Three Components in the Topical ABH Gel in Healthy Volunteers, and Determine if There Are Any Adverse Effects.

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Trial Information

Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers


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.


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Lorazepam, Diphenyhydramine, Haloperidol Absorption

Outcome Description:

Level of lorazepam absorption measured by the serum concentration of the drug

Outcome Time Frame:

4 hours

Safety Issue:

No

Principal Investigator

Thomas Smith

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University

Authority:

United States: Federal Government

Study ID:

MCC-13108

NCT ID:

NCT01204255

Start Date:

November 2010

Completion Date:

May 2011

Related Keywords:

  • Focus of Study: Absorption of the Three Components in the Topical ABH Gel in Healthy Volunteers, and Determine if There Are Any Adverse Effects.
  • healthy, no evidence of disease

Name

Location

Virginia Commonwealth University/Massey Cancer CenterRichmond, Virginia  23298