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Protocol Summary for 112558

Protocol Summary
Protocol Id: 112558
Secondary Ids:
Title: A single dose and repeat dose study to investigate the pharmacokinetics of ropinirole after single and multiple doses of a PR-formulation in Chinese healthy male and female subjects
Phase: phase 1
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: No
Delayed Posting: No
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • China: Ethics Review Board
  • China State Food and Drug Administration
  • United States: Institutional Review Board
  • United States:Food and Drug Administration,
Collaborators:
Brief Summary: The purpose of this study is to investigate the pharmacokinetic profile of ropinirole PR after single and multiple doses of the PR-formulation. It will also investigate the safety and tolerability of ropinirole PR after single and multiple doses of PR-formulation.
Detailed Description:
Record Verification Date: September 2011
Status: Completed
Why Study Stopped:
Study Start Date: June 2010
Study Completion Date: August 2010
Study Completion Date Type: Actual
Primary Completion Date: August 2010
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Open Label
Masked Subject: no
Masked Caregiver: no
Masked Investigator: no
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Pharmacokinetics/dynamics Study
Primary Outcomes:
  • Profile of Pharmacokinetics predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing
  • Profile of Pharmacokinetics predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24,36,48,72, 96,120,144,168 hours post-dose
Secondary Outcomes:
  • Composition of Pharmacokinetics predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing
  • Profile of Pharmacokinetics pre-dose,1,2,3,4,6,8,10,12,14,16,18,20,22, 24,36,48,72,96,120,144,168hours post-dose
Conditions:
  • Parkinson Disease
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 45 Year
Enrollment: 24
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information