Status:
COMPLETED
KF2022#3-trial: Effect of Tea and Cola Beverage on Absorption of Risperidone Oral Solution
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
University of Helsinki
Conditions:
Psychosis
Food-drug Interaction
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06218979
Start Date
December 8 2023
End Date
March 14 2024
Last Update
December 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Clinical Pharmacology
Helsinki, Finland