A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa)... | NCT00460954

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

NCT00460954

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Aug 14, 2008Estimated

Enrollment

20Estimated

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Sinemet® controlled release (Carbidopa/levodopa)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2007

Primary Completion Date

Not provided

Completion Date

Aug 2007Actual

First Submitted Date

Apr 16, 2007

First Submission Date that Met QC Criteria

Apr 16, 2007

First Posted Date

Apr 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 13, 2008

Last Update Posted Date

Aug 14, 2008Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Name	Type	Description	Arm Group Labels	Other Names
Sinemet® controlled release (Carbidopa/levodopa)	Drug

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Toronto	Ontario	M5V 2T3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002230	Carbidopa
D007980	Levodopa

Ancestor Terms

ID	Term
D008750	Methyldopa
D004295	Dihydroxyphenylalanine
D002395	Catecholamines
D000588	Amines

Browse Leaves

Not provided

Browse Branches

Not provided