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Dose-finding Pharmacokinetic Study in Healthy Males

NCT03055936 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-05-27

Study results available
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Summary

This is a phase I PK study in healthy males.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Levodopa

Levodopa 50 mg or 100 mg or 150 mg

DRUG

Carbidopa

Carbidopa 12.5 mg or 25 mg or 65 mg

DRUG

ODM-104

ODM-104 50 mg or 100 mg

Sponsors & Collaborators

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Denis Strugala, DR.med. · Nuvisan GmbH

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
2017-02-21
Primary Completion
2017-06-09
Completion
2017-06-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT03055936 on ClinicalTrials.gov