Pharmacokinetic profile of betahistine blood concentration with and without selegiline in healthy volunteers - a mono-center, open-labeled phase I trial
- Conditions
- healthy volunteers
- Registration Number
- DRKS00023352
- Lead Sponsor
- MU Klinikum Neurologische Klinik und Poliklinik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
•healthy volunteers (age = 18 years and = 70 years) as determined by screening and Principal Investigator's judgement
•no intake of medication due to an illness
•written informed consent of the subject
•systolic blood pressure between 90 and 140 mmHg and diastolic blood pressure between 60 and 90 mmHg at screening
•PQ interval in the ECG between 0.12 s and 0.20 s
•duration of the QRS complex between 0.06 s and 0.10 s
•QTc intervall 440 ms or less
•heart rate between 60 and 100 beats per minute
•subjects with the ability to follow study instructions and likely to attend and complete all required visits
•subject is not able to give consent
•a condition in which repeated blood draws or injections pose more than minimal risk for the subjects, such as hemophilia, other severe coagulation disorders or significantly impaired venous access
•participation in another study with an investigational drug or device within the last 30 days, prior participation in the present study, or planned participation in another trial
•intake of medication due to an illness
•subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in the clinical trial
•current or planned pregnancy or nursing woman
•woman of childbearing potential who are not willing to use medically reliable methods of contraception for the entire study duration
•intake of alcohol 24 hours before first IMP intake or during study participation
•known or persistent abuse of medication, drugs or alcohol (positive test for alcohol or drugs)
•known contraindications of betahistine, such as bronchial asthma, pheochromocytoma, treatment with antihistaminic drugs, ulcer of the stomach or duodenum, severe dysfunction of liver or kidney,hypersensitivity to betahistine or other ingredients
•known contraindications to selegiline, e.g. use of opioids, tricyclic antidepressants, sympathomimetics, non-selective MAOIs, (selective) serotonin (-noradrenaline) re-uptake inhibitors (SSRI/SNRI), serotonin agonists, hypersensitivity to selegiline or other ingredients
•hereditary intolerance of galactose, hereditary deficiency of lactose, glucose-galactose-malabsorption
•AV Block in the ECG
•hypotonic or hypertonic subjects according to the criteria of the National Heart, Lung and Blood Institute (Hypertension >140/90 mmHg, Hypotension <90/60 mmHg)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve (AUC 0-240 min) of the blood concentrations of betahistine and 2-pyridylacetic acid (2-PAA) after combination treatment with betahistine and 5 mg/d selegiline compared to betahistine monotherapy, giving single dosages of betahistine of 24, 48, 96 mg in ascending dosage
- Secondary Outcome Measures
Name Time Method Half-life time of betahistine and 2-PAA in blood after intake of different dosages of betahistine, and occurrence of adverse effects of the combination treatment with betahistine and selegiline