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The objective of this study is to investigate the effect of safinamide on levodopa blood levels, both after single and multiple dosing of safinamide . A further objective of the study is to assess the safety and tolerability of safinamide when given together with levodopa in the applied regimen.
For that purpose, all study participants will undergo intensive blood sampling for investigation of levodopa levels and various tolerability examinations, such as the measurement of vital signs (blood pressure, pulse, body temperature), recording of ECGs and questioning to find out how the study participants are feeling. Furthermore, blood samples will be drawn and urine tests will be performed repeatedly for safety purpose during the course of the study.
The results of this clinical trial may be used for the drug registration of safinamide in the future.
Full description
Treatments are given in a crossover design.
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Inclusion criteria
Exclusion criteria
To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
24 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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