Pharmacokinetic Profile of Betahistine With and Without Selegiline in Healthy Volunteers (NCT05938517) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic Profile of Betahistine With and Without Selegiline in Healthy Volunteers
Germany15 participantsStarted 2021-06-02
Plain-language summary
The goal of this pharmakokinetic trial is to demonstrate that Betahistine serum concentration is higher after combination treatment with Betahistine and Selegiline compared to Betahistine alone.
The main questions it aims to answer are:
Is the plasma concentration of betahistine higher due to combination treatment with selegiline compared to betahistine monotherapy? How is the safety of the combination treatment with betahistine and selegiline, the pharmacokinetics of betahistine in different dosages in blood, and the inter-individual differences in the metabolism?
Subjects satisfying all selection criteria will receive three different dosages of Betahistine alone orally in ascending order (24 mg, 48 mg, 96 mg) in the first period. In the second period, subjects received Betahistine treatment as described for first period but after pre- and continuous treatment with 5 mg/ml Selegiline orally. Plasma concentration (namely the AUC0-240min) of betahistine will be measured before and 10, 30, 60, 90, 120, 180, 240 minutes after treatment with blood examinations. Safety parameters include assessment of adverse events, ECG, vital signs, laboratory measurements including kidney and liver function, full blood count and pregnancy and drug screening test.
Who can participate
Age range18 Years – 70 Years
SexALL
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Diagnosis and main criteria for inclusion:
* Adult healthy volunteers, males and non-pregnant, non-breastfeeding woman with adequate contraception
* Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the trial:
* 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 interval 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
Subjects presenting with any of the following exclusion criteria were not included in the trial:
* Subject is not able to give consent
* A condition in which repeated serum draws or injections pose more than minimal risk for the subjects, such as haemophilia, 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 inv…