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

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.

Timeline

Start

2023-12-08

Primary completion

2024-03-14

Completion

2024-03-14

Drugs

Indications