Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
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.