Pharmacokinetic Profile of Betahistine With and Without Selegiline in Healthy Volunteers
- Conditions
- Ménière's Disease
- Interventions
- Drug: Selegiline-hydrochloride
- Registration Number
- NCT05938517
- Lead Sponsor
- Ludwig-Maximilians - University of Munich
- Brief 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.
- Detailed Description
This study was an investigator-initiated (IIT) prospective mono-center open-labeled trial to demonstrate that Betahistine serum concentration is higher after combination treatment with Betahistine and Selegiline compared to Betahistine alone in healthy subjects.
Subjects were screened for their eligibility to participate in the study. Each subject gave written informed consent before any study-related procedures were performed.
Subjects satisfying all selection criteria were included in the open-labeled trial receiving 3 different dosages of Betahistine alone 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. Betahistine serum concentrations were measured over a period of 240 min at 8 time points (area under the curve, AUC0-240 min). Safety parameters included assessment of adverse events, ECG, vital signs, laboratory measurements including kidney and liver function, full blood count and pregnancy and drug screening test). Safety monitoring was conducted during every visit and assessment of vital parameter and adverse events were conducted 10, 30, 60, 90, 120, 180, and 240min after betahistine intake. The clinical trial was conducted in a hospital of maximum care with the possibility to consult a specialist for possible symptoms of an intoxication especially an anesthesiologist, cardiologist and neurologist 24 hours/7 days a week.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Betahistine-dihydrochloride and Selegiline-hydrochloride Selegiline-hydrochloride Subjects were pre-treated with Selegiline (5 mg/day) orally for one week and treated continuously with Selegiline (5 mg/day) in combination with the single dosages of Betahistine (24 mg, 48 mg, 96 mg) orally with at least two days between the different dosages. Betahistine-dihydrochloride Betahistine dihydrochloride Subjects received single dosages of Betahistine (24 mg, 48 mg, 96 mg) orally for pharmacokinetic serum draw with at least two days between the different dosages. Betahistine-dihydrochloride and Selegiline-hydrochloride Betahistine dihydrochloride Subjects were pre-treated with Selegiline (5 mg/day) orally for one week and treated continuously with Selegiline (5 mg/day) in combination with the single dosages of Betahistine (24 mg, 48 mg, 96 mg) orally with at least two days between the different dosages.
- Primary Outcome Measures
Name Time Method Mean AUC of Betahistine 240 minutes Mean AUC of Betahistine in serum after treatment of Betahistine alone or with Selegiline
- Secondary Outcome Measures
Name Time Method Mean Half Life of Betahistine 240 minutes Half Life of Betahistine following the administration of different Betahistine doses with and without Selegiline
Occurrence of adverse effects up to 8 weeks Occurrence of adverse effects following the administration of different Betahistine doses with and without Selegiline
Trial Locations
- Locations (1)
Department of Neurology, Ludwig Maximilian University
🇩🇪Munich, Bavaria, Germany