drugset / Trial / NCT01070628

Levodopa Concentration Profile With Stalevo 75/125 mg

NCT01070628

Phase 1 Completed 20 enrolled Orion Corporation, Orion Pharma
RandomizedCrossoverOpen-labelTreatment

Summary

The purpose of this study is to confirm that the dose levels and dosing frequency utilising the new Stalevo strengths would result into more stable levodopa plasma levels. Therefore, it is anticipated that when lower dose of Stalevo is administered after the first higher dose of Stalevo, this would result in equally high levodopa maximum concentration values (Cmax) after each dose throughout the day compared to Cmax after the first dose.

Timeline

Start
2009-12
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levodopa Small molecule 100 mg
Comparator Levodopa Small molecule 150 mg
Subject Stalevo Unknown 75 mg
Subject Stalevo Unknown 100 mg
Subject Stalevo Unknown 125 mg
Subject Stalevo Unknown 150 mg

Indications