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A Single Dose Pharmacokinetic Study of Topical and Rectal Quetiapine Compared to Oral Quetiapine in Healthy Adults
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
Yes
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Start Date
June 1, 2014
Primary Completion Date
July 1, 2016
Completion Date
July 1, 2016
Last Updated
April 25, 2017
10
ACTUAL participants
Quetiapine 25 mg gel applied topically
DRUG
Quetiapine 25 mg tablet by mouth
DRUG
Quetiapine 25 mg rectal suppository
DRUG
Quetiapine 25 mg gel applied topically
DRUG
Lead Sponsor
Mayo Clinic
NCT07357389
NCT04246437
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05508789