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Pharmacokinetic of Levodopa Study in Healthy Males

NCT03140956 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-09-26

No results posted yet for this study

Summary

The purpose of the study is to investigate PK of levodopa in plasma after repeated doses of 3 levodopa formulations given in combination with carbidopa and ODM-104 and compared to the PK of standard IR and CR levodopa formulations in the same combination.

Conditions

  • Parkinson Disease

Interventions

DRUG

Levodopa, carbidopa, ODM-104

Crossover design. Study treatments will be administered in randomized order 4 times a day.

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-19
Primary Completion
2017-07-03
Completion
2017-08-03

Countries

  • Finland

Study Locations

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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 NCT03140956 on ClinicalTrials.gov