NCT01070628

Levodopa Concentration Profile With Stalevo 75/125 mg

Levodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel Groups

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Orion Corporation, Orion Pharma · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Stalevo (levodopa/ carbidopa/ entacapone)	150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval
DRUG	Sinemet (levodopa/carbidopa)	150 or 100 mg levodopa q.i.d. in 3.5 hr interval

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2010-02-18
• Last updated: 2010-08-13

Locations

1 site across 1 country: Finland