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

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 1

Conditions: Psychosis; Food-drug Interaction

Treatments: Drug: Risperidone oral solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06218979

KF2022#3

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups, including a placebo group

Control phase

Placebo Comparator group

Description:

Study drug dose (1 mg risperidone) and 250 ml of water at 8:00 a.m., and 250 ml of water at 8:30 a.m.

Treatment:

Drug: Risperidone oral solution

Tea phase

Active Comparator group

Description:

Study drug dose (1 mg risperidone) and 250 ml of tea at 8:00 a.m., and 250 ml of tea at 8:30 a.m.

Treatment:

Drug: Risperidone oral solution

Cola beverage phase

Active Comparator group

Description:

Study drug dose (1 mg risperidone) and 250 ml cola drink at 8:00 a.m., and 250 ml cola beverage at 8:30 a.m.

Treatment:

Drug: Risperidone oral solution