A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects

This study has been completed.

First Received: April 16, 2007 Last Updated: August 13, 2008 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00460954

Purpose

The purpose of this clinical research study is to determine if different dosage regimens of Sinemet® CR (Carbidopa/levodopa) are dose proportional

Condition	Intervention
Parkinson's Disease	Drug: Sinemet® controlled release (Carbidopa/levodopa)

Study Type:	Observational
Study Design:	Prospective
Official Title:	An Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa Carbidopa Sinemet

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment:	20
Study Start Date:	June 2007
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	50 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Key inclusion and exclusion criteria for healthy volunteers will be used
Males and females aged 50-75

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460954

Locations

Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5V 2T3

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CN158-001
Study First Received:	April 16, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00460954 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Additional relevant MeSH terms:

Neurotransmitter Agents
Levodopa
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Basal Ganglia Diseases
Nervous System Diseases
Carbidopa
Adjuvants, Immunologic
Central Nervous System Diseases
Antiparkinson Agents

Enzyme Inhibitors
Dopamine Agonists
Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Parkinson Disease
Movement Disorders
Therapeutic Uses
Sinemet
Dopamine Agents
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009