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Levodopa Concentration Profile With Stalevo 75/125 mg

NCT01070628 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-08-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Kimmo Ingman · Orion Corporation, Orion Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01070628 on ClinicalTrials.gov