A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
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.