NCT06218979

KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution

KF2022#3-tutkimus: Teen Ja Kolajuoman Vaikutus Risperidoni-oraaliliuoksen Imeytymiseen

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Risperidone is widely used in the treatment of schizophrenia, bipolar disorder, and aggression associated with moderate or severe Alzheimer's dementia. In vitro studies have shown that constituents of tea and cola beverages can result in insoluble complex formation with risperidone, potentially reducing risperidone oral absorption. The purpose of this study is to investigate the effect of tea and cola beverage on the pharmacokinetics of risperidone oral solution. In an open three-phase, randomized, crossover study with 12 healthy volunteers, the subjects will receive a 1 mg dose of risperidone oral solution with either water, tea or cola beverage. Blood samples will be collected and risperidone's pharmacokinetics will be monitored up to 48 hours postdose. Primary endpoint is area under the plasma concentration-time curve of risperidone. Recruitment starting date is December 4, 2023.

Conditions

• Psychosis
• Food-drug Interaction

Interventions

Type	Name	Description
DRUG	Risperidone oral solution	See arm/group descriptions

Timeline

• Start date: 2023-12-08
• Primary completion: 2024-03-14
• Completion: 2024-03-14
• First posted: 2024-01-23
• Last updated: 2024-12-05

Locations

1 site across 1 country: Finland