Status:
NOT_YET_RECRUITING
KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism
Lead Sponsor:
Helsinki University Central Hospital
Collaborating Sponsors:
University of Helsinki
Conditions:
Drug Interaction
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Carvedilol is a non-selective beta-blocker in common clinical use, used to treat hypertension, heart failure, and angina pectoris symptoms associated with coronary artery disease. Diclofenac is a non-...
Eligibility Criteria
Inclusion
- Written informed consent
- Age 18-40
- Healthy
- Systolic blood pressure ≥110 mmHg
- Heart rate ≥ 55/min
- Normal ECG
- Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatine kinase, creatinine, plasma glucose concentration, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
Exclusion
- Significant disease
- Previous or current gastrointestinal bleeding, ulcer or perforation
- Findings of a medical examination and laboratory tests, which require a more detailed examination of the state of health
- Smoking
- Hormonal birth control 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
- Hypersensitivity or contraindication to study drugs
Key Trial Info
Start Date :
August 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06566794
Start Date
August 20 2024
End Date
December 31 2025
Last Update
August 22 2024
Active Locations (1)
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1
Department of Clinical Pharmacology
Helsinki, Finland