Food-drug Interaction, Psychosis
Conditions
Brief 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.
Interventions
See arm/group descriptions
Sponsors
University of Helsinki
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent * Age 18-45 * Healthy * Systolic blood pressure ≥110 mmHg * Heart rate ≥ 50/min * Normal ECG * Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
Exclusion criteria
* Significant disease * Mood disorder or suicidality * Smoking * Using oral contraception pills or other regular medication * Pregnancy (current or planned) or nursing * Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study * Donation of blood within three months prior to the entry into this study * Significant overweight / small or hard-to-find veins * BMI \< 18.5 kg/m2 * Insufficient Finnish language skills
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration - time curve of risperidone | Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone |
Secondary
| Measure | Time frame |
|---|---|
| Peak plasma concentration for both risperidone and its metabolites | Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone |
| Half-life for both risperidone and its metabolites | Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone |
| Fractional areas under concentration-time curve (AUC) for both risperidone and its metabolites | Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone |
| Time to peak plasma concentration for both risperidone and its metabolites | Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone |
| CYP2D6 activity biomarkers (solanidine and its metabolites) | Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone |
| Areas under concentration-time curve (AUC) for risperidone metabolites | Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone |
Countries
Finland
Outcome results
None listed