Quetiapine, a second generation antipsychotic, is only available as oral tablets. However, topical and rectal formulations have been produced in compounding pharmacies. There is no data available suggesting that topical or rectal formulations provide serum levels similar to oral medication. In the clinical setting, when oral administration of quetiapine is not possible (for example, when a patient is extremely ill physically or mentally or both), clinicians and pharmacists have collaborated in such cases and have at times had to administer quetiapine compounded in other dosage formulations such as rectal or topical formulations. Despite clinical effectiveness of these other formulations, there are no available studies that have investigated blood levels of the drug other than the oral form. The investigators are therefore designing this pharmacokinetic study to evaluate the the systemic absorption of quetiapine in oral, rectal and topical formulations. If the investigators are able to demonstrate detectable levels from rectal and topical quetiapine formulations compared to the oral form, this knowledge will enhance clinical psychiatric practice by providing a more broad route of administration for quetiapine which is a commonly used drug for psychiatric symptoms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
10
Quetiapine 25 mg gel applied topically; 9 serum quetiapine levels drawn over the course of 8 hours
Quetiapine 25 mg tablet administered by mouth; 9 serum quetiapine levels drawn over the course of 8 hours
Quetiapine 25 mg suppository administered rectally; 9 serum quetiapine levels drawn over the course of 8 hours
Quetiapine 75 mg gel applied topically every 4 hours for 24 hours; 6 serum quetiapine levels drawn over the course of 24 hours
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Serum quetiapine levels after topical application (Visit 1)
Areas under the curve versus time
Time frame: 8 hours
Serum quetiapine levels after oral administration (Visit 2)
Areas under the curve versus time
Time frame: 8 hours (no sooner than 72 hours from end of visit 1)
Serum quetiapine levels after rectal administration (Visit 3)
Areas under the curve versus time
Time frame: 8 hours (no sooner than 72 hours from end of visit 2)
Serum quetiapine levels after topical administration over 24 hours
Topical quetiapine applied every 4 hours for 24 hours
Time frame: 24 hours
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