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Pharmacokinetic Study in Healthy Volunteers | Clinical Trials | Clareo Health

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Pharmacokinetic Study in Healthy Volunteers

Pharmacokinetics of Levodopa After Repeated Doses of Carbidopa, ODM-104 and Levodopa: an Open, Randomised Study With Crossover Design in Healthy Males and Females

NCT02554734•Orion Corporation, Orion Pharma

View on ClinicalTrials.gov

Summary

Phase I open, randomized cross-over pharmacokinetic study.

Detailed Description

The purpose of this study is to investigate the pharmacokinetics of levodopa, carbidopa, 3-OMD and ODM-104 after repeated doses of levodopa, carbidopa and ODM-104: an open, randomized, multicenter study with crossover design in healthy males and females.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Written informed consent (IC) obtained
•Good general health ascertained by detailed medical history and physical examinations
•Finnish speaking males and females 18-65 years of age
•Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI=weight/height m2)
•Weight at least 55 kg
•Regular intestinal transit (no recent history of recurrent constipation, diarrhea, or other intestinal problems, and no history of major gastrointestinal surgery)
•Sexually active study subjects, unless surgically sterile must adhere to a proper form of contraception (hormonal contraception or intrauterine device on female partner, and an additional barrier method used at least by one of the partners) from the first study treatment administration until 3 months after the end-of-study visit

Exclusion Criteria

•Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease or cancer (except local non-melanoma skin cancer) within the previous 2 years.
•Family history (parents, siblings) of clinically significant cardiac conduction disease.
•Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol for occasional pain is allowed. Hormonal contraception and hormone replacement therapy are allowed.
•Intake of any medication that could affect the outcome of the study.
•Any clinically significant abnormal laboratory value or physical finding (including ECG and vital signs) that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject if he/she takes part in the study.
•Known hypersensitivity to the active substances or the excipients of the drugs.
•Pregnant or lactating females.
•History of vasovagal collapses or vagal reactions with unexplained reason within the previous 2 years or a tendency for vasovagal reactions during blood sampling.
•HR \< 40 bpm or \> 90 bpm in the supine position after 10 min rest at the screening visit.
•At the screening visit:
+12 more criteria

Locations (1)

Clinical Research Services Turku CRST

Turku, Finland

Key Dates

Start Date

August 1, 2015

Primary Completion Date

November 1, 2015

Completion Date

November 1, 2015

Last Updated

January 14, 2016

Enrollment

ACTUAL participants

Conditions

Parkinson's Disease

Interventions

levodopa, carbidopa, ODM-104

DRUG

levodopa, carbidopa, entacapone

DRUG

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGNA

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

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RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetic Study in Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Deep Brain Stimulation Therapy in Movement Disorders

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations