Protocol Summary for 112558
| Protocol Id: | 112558 |
| Secondary Ids: |
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| 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 |
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| 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: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion 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
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Click to view inclusion/exclusion criteria