Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ropinirole
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy adult men and women between 18 and 45 years of age, inclusive.
- Body weight >=50Kg.
- Body Mass Index (BMI) 19 - 24 kg/m2.
- No abnormality on clinical examination.
- No abnormality revealed by the clinical chemistry or haematology examination at the pre-study medical examination.
- A normal 12-lead ECG at the pre-study screening.
- Normal systolic (100-140mmHg) and diastolic (<90mmHg) blood pressure at pre-study screening.
- Written informed consent prior to admission to the study.
Exclusion Criteria:
- Any clinically relevant abnormality identified on the screening history and physical or laboratory examination significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
- Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure.
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- The subject has received prescribed medication within 7 days prior to the first dosing day, which in the opinion of the principal medical investigator interfered with the study procedures or compromised safety.
- The subject has received over-the-counter (OTC) medicine within 48 hours prior to the first study day. Subjects who took OTC medication could still be entered into the study, if, in the opinion of the principal/co-investigator, the medication received did not interfere with the study procedures or compromised safety of the subjects.
- Abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units. One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine.
- Positive screen for addictive drugs and tobacco.
- Participation in a trial with any drug within the 1 month before the start of the study.
- Either blood donation within the previous 3 months, or donation of a quantity of blood within the previous 12 months that would result in the subject having donated more than 1,500mL blood in a period from 12 months before this study up to and including the end of the study.
- Positive pre-study screening result for hepatitis B antigen, hepatitis C antibody and HIV-1/2 antibodies.
- Pregnancy and/or lactation;
- Female subjects of childbearing potential who are intending to become pregnant and/or are not willing to avoid pregnancy by means of barrier contraception methods (i.e. condoms or IUD) during the study from 5 days prior to screening or in the 3 months following the study.
- Female subjects with positive serum hCG test result at screening or on Days 1 of both study phases with positive urine HCG test.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects receiving ropinirole
Arm Description
Eligible subjects will receive single and multiple oral dose of ropinirole prolonged release tablet in sequence over 14 days without dosing on washout period from Day 2 to Day 7.
Outcomes
Primary Outcome Measures
Profile of Pharmacokinetics
Cmax, AUC (0-24), AUC(0-inf)
Profile of Pharmacokinetics
Css_max, Css_min and AUCss
Secondary Outcome Measures
Profile of Pharmacokinetics
Tmax, T1/2, Kel
Composition of Pharmacokinetics
Tmax, Css_av, DF,accumulation ratios (Ro and Rs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01435915
Brief Title
Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 28, 2010 (Actual)
Primary Completion Date
August 5, 2010 (Actual)
Study Completion Date
August 5, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects receiving ropinirole
Arm Type
Experimental
Arm Description
Eligible subjects will receive single and multiple oral dose of ropinirole prolonged release tablet in sequence over 14 days without dosing on washout period from Day 2 to Day 7.
Intervention Type
Drug
Intervention Name(s)
Ropinirole
Intervention Description
Ropinirole 2 milligrams once daily prolonged release tablet will be given at 24-hour intervals in the morning.
Single and repeat dose treatment periods will be separated by 7 days of washout period.
Primary Outcome Measure Information:
Title
Profile of Pharmacokinetics
Description
Cmax, AUC (0-24), AUC(0-inf)
Time Frame
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
Title
Profile of Pharmacokinetics
Description
Css_max, Css_min and AUCss
Time Frame
predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing
Secondary Outcome Measure Information:
Title
Profile of Pharmacokinetics
Description
Tmax, T1/2, Kel
Time Frame
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
Title
Composition of Pharmacokinetics
Description
Tmax, Css_av, DF,accumulation ratios (Ro and Rs)
Time Frame
predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult men and women between 18 and 45 years of age, inclusive.
Body weight >=50Kg.
Body Mass Index (BMI) 19 - 24 kg/m2.
No abnormality on clinical examination.
No abnormality revealed by the clinical chemistry or haematology examination at the pre-study medical examination.
A normal 12-lead ECG at the pre-study screening.
Normal systolic (100-140mmHg) and diastolic (<90mmHg) blood pressure at pre-study screening.
Written informed consent prior to admission to the study.
Exclusion Criteria:
Any clinically relevant abnormality identified on the screening history and physical or laboratory examination significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
Definite or suspected personal history or family history of adverse reactions or hypersensitivity to the study drug or to drugs with a similar chemical structure.
History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
The subject has received prescribed medication within 7 days prior to the first dosing day, which in the opinion of the principal medical investigator interfered with the study procedures or compromised safety.
The subject has received over-the-counter (OTC) medicine within 48 hours prior to the first study day. Subjects who took OTC medication could still be entered into the study, if, in the opinion of the principal/co-investigator, the medication received did not interfere with the study procedures or compromised safety of the subjects.
Abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units. One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine.
Positive screen for addictive drugs and tobacco.
Participation in a trial with any drug within the 1 month before the start of the study.
Either blood donation within the previous 3 months, or donation of a quantity of blood within the previous 12 months that would result in the subject having donated more than 1,500mL blood in a period from 12 months before this study up to and including the end of the study.
Positive pre-study screening result for hepatitis B antigen, hepatitis C antibody and HIV-1/2 antibodies.
Pregnancy and/or lactation;
Female subjects of childbearing potential who are intending to become pregnant and/or are not willing to avoid pregnancy by means of barrier contraception methods (i.e. condoms or IUD) during the study from 5 days prior to screening or in the 3 months following the study.
Female subjects with positive serum hCG test result at screening or on Days 1 of both study phases with positive urine HCG test.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Beijing
ZIP/Postal Code
100032
Country
China
12. IPD Sharing Statement
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Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
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