Evidence of Haloperidol Absorption After Topical Administration

Eric E. Prommer

Status and phase: Withdrawn; Early Phase 1

Conditions: Vomiting; Nausea

Treatments: Drug: Haloperidol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01684969

11-005661

Details and patient eligibility

About

This will be a blinded study to compare the absorption of topical haloperidol with placebo

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Age: patient must be 18 years or older and less than 70 years of age.
• Provision of informed consent
• No previous adverse reaction to haloperidol
• No current use of haloperidol
• Good health
• No alcohol within 24 hours of the study
• No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
• Normal neurologic exam

Exclusionary Criteria

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
• Recent cerebral trauma
• Study will exclude women who are pregnant and/or nursing
• Women who are of child bearing potential must have a negative urine pregnancy test.
• History of seizures
• Taking medications that can interact with haloperidol
• Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

intravenous haloperidol

Active Comparator group

Description:

intravenous haloperidol pharmacokinetics

Treatment:

Drug: Haloperidol

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo