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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00460954
First received: April 16, 2007
Last updated: August 13, 2008
Last verified: August 2008
  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: 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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 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:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Carbidopa
Carbidopa, levodopa drug combination
Levodopa
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 November 25, 2014