A Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics

Status Completed

Clinical Trial 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.

Clinical Trial Description

Treatments are given in a crossover design. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01026428
Study type	Interventional
Source	Newron
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	September 2009

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