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

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

Date First Received: April 16, 2007

Last Updated: August 13, 2008

Verified by: Bristol-Myers Squibb, August 2008

Clinical Trial Phase: N/A | Start Date: June 2007

Overall Status: Completed

Estimated Enrollment: 20

Brief Summary

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”

Condition Keyword(s):

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

Study Type: Observational

Study Design: Prospective

Intervention(s) in this Clinical Trial

  • Drug: Sinemet® controlled release (Carbidopa/levodopa)

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Sponsor Information

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Additional Information

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00460954

Study ID Number: CN158-001

ClinicalTrials.gov Identifier: NCT00460954

Health Authority: United States: Food and Drug Administration

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