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

NCT ID: NCT06218979

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2024-03-14

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.

Conditions

Psychosis; Food-drug Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Control phase

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.

Group Type: PLACEBO_COMPARATOR

Risperidone oral solution

Intervention Type: DRUG

See arm/group descriptions

Tea phase

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.

Group Type: ACTIVE_COMPARATOR

Risperidone oral solution

Intervention Type: DRUG

See arm/group descriptions

Cola beverage phase

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.

Group Type: ACTIVE_COMPARATOR

Risperidone oral solution

Intervention Type: DRUG

See arm/group descriptions

Interventions

Risperidone oral solution

See arm/group descriptions

Intervention Type: DRUG

Other Intervention Names

Twinings English Breakfast tea; Pepsi Max beverage

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Janne Backman

Professor, head physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janne Backman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor, Head physician

Locations

Department of Clinical Pharmacology

Helsinki, , Finland

Countries

Finland

Other Identifiers

KF2022#3

Identifier Type: -

Identifier Source: org_study_id