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NCT Number: NCT06218979

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

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.

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Key information

Conditions

Psychosis Food-drug Interaction Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Clinical Pharmacology

Helsinki, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Risperidone oral solution

Drug

See arm/group descriptions

Other names: Twinings English Breakfast tea, Pepsi Max beverage

Primary outcomes

  1. Area under the plasma concentration - time curve of risperidone

    Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone

Secondary outcomes

  1. Peak plasma concentration for both risperidone and its metabolites

    Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone

  2. Half-life for both risperidone and its metabolites

    Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone

  3. Time to peak plasma concentration for both risperidone and its metabolites

    Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone

  4. Fractional areas under concentration-time curve (AUC) for both risperidone and its metabolites

    Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone

  5. Areas under concentration-time curve (AUC) for risperidone metabolites

    Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone

  6. CYP2D6 activity biomarkers (solanidine and its metabolites)

    Time frame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 11, 24, and 48 hours after administration of risperidone

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • University of Helsinki

Registry information

Official study title

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

Acronym: KF2022#3

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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