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

This study has been completed.
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
First received: April 16, 2007
Last updated: August 13, 2008
Last verified: August 2008

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: 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

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
  • Key inclusion and exclusion criteria for healthy volunteers will be used
  • Males and females aged 50-75
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00460954

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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Carbidopa, levodopa drug combination
Adjuvants, Immunologic
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Enzyme Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on March 25, 2015