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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01435915 |
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Date of registration:
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01/09/2011 |
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Primary sponsor: |
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Public title:
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Ropinirole PR Pharmacokinetics Study Among Chinese Healthy Subjects
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Scientific title:
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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 |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01435915 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: Ropinirole
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Primary Outcome(s)
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Profile of Pharmacokinetics
[Time Frame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing]
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Profile of Pharmacokinetics
[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]
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Secondary Outcome(s)
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Composition of Pharmacokinetics
[Time Frame: predose,1,2,3,4,6,8,10,12,14,16,18,20,22,24 hours after last repeated dosing]
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Profile of Pharmacokinetics
[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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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