Last updated: 11/07/2018 04:51:18
Ropinirole PR pharmacokinetics study among Chinese healthy subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Profile of Pharmacokinetics
Timeframe: 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
Profile of Pharmacokinetics
Timeframe: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing
Secondary outcomes:
Profile of Pharmacokinetics
Timeframe: 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
Composition of Pharmacokinetics
Timeframe: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing
Interventions:
Drug: Ropinirole
Enrollment:
24
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Hongzhong Liu; Ji Jiang; Hongyun Wang; Xia Chen; Tao Liu; Haijun Cao; Jonathan Palmer; Anita Gu; Pei Hu.You have full text access to this contentA single and multiple dose study to investigate the pharmacokinetics of a prolonged release formulation of ropinirole in healthy Chinese subjects.Clin Pharmacol Drug Devel.2014;3(2):84-92
Medical condition
Parkinson Disease
Product
ropinirole
Collaborators
Not applicable
Study date(s)
June 2010 to August 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- 1. Healthy adult men and women between 18 and 45 years of age, inclusive.
- 2. Body weight >=50Kg.
- 1. Any clinically relevant abnormality identified on the screening history and physical or laboratory examination significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities.
- 2. 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Healthy adult men and women between 18 and 45 years of age, inclusive. 2. Body weight >=50Kg. 3. Body Mass Index (BMI) 19
- 24 kg/m2. 4. No abnormality on clinical examination. 5. No abnormality revealed by the clinical chemistry or haematology examination at the pre-study medical examination. 6. A normal 12-lead ECG at the pre-study screening. 7. Normal systolic (100-140mmHg) and diastolic (<90mmHg) blood pressure at pre-study screening. 8. Written informed consent prior to admission to the study.
Exclusion criteria:
- 1. Any clinically relevant abnormality identified on the screening history and physical or laboratory examination significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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. 7. Positive screen for addictive drugs and tobacco. 8. Participation in a trial with any drug within the 1 month before the start of the study. 9. 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. 10. Positive pre-study screening result for hepatitis B antigen, hepatitis C antibody and HIV-1/2 antibodies. 11. Pregnancy and/or lactation; 12. 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. 13. Female subjects with positive serum hCG test result at screening or on Days 1 of both study phases with positive urine HCG test.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-05-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 112558 can be found on the GSK Clinical Study Register.
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