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

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ClinicalTrials.gov Identifier: NCT00460954
Recruitment Status : Completed
First Posted : April 17, 2007
Last Update Posted : August 14, 2008
Sponsor:
Information provided by:
Bristol-Myers Squibb

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

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

Study Type : Observational
Estimated Enrollment : 20 participants
Time Perspective: 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
Study Start Date : June 2007
Study Completion Date : August 2007

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U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Key inclusion and exclusion criteria for healthy volunteers will be used
  • Males and females aged 50-75

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460954


Locations
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5V 2T3
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
ClinicalTrials.gov Identifier: NCT00460954     History of Changes
Other Study ID Numbers: CN158-001
First Posted: April 17, 2007    Key Record Dates
Last Update Posted: August 14, 2008
Last Verified: August 2008

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Carbidopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic
Immunologic Factors
Dopamine Agonists