NCT06218979CompletedPhase 1
KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution
KF2022#3-tutkimus: Teen Ja Kolajuoman Vaikutus Risperidoni-oraaliliuoksen Imeytymiseen
Source: ClinicalTrials.gov · Last updated 5 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 4 Dec 2023
- Start date
- 8 Dec 2023
- Primary completion date
- 14 Mar 2024
- Lead sponsor
- Helsinki University Central Hospital
- Diseases
- Schizophrenia
- NCT number
- NCT06218979
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From 8 Dec 2023 to the primary completion date, 14 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Using oral contraception pills or other regular medication
- 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
Other illness
- Significant disease
- Mood disorder or suicidality
Other
- Smoking
- Pregnancy (current or planned) or nursing
- Significant overweight / small or hard-to-find veins
- BMI \< 18.5 kg/m2
- Insufficient Finnish language skills
Who the study is looking for
- 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.
Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Clinical Pharmacology Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.