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35977

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Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the eligibility criteria. It has to be filled in for screening.

Nyckelord

Versioner (1)
  1. 2019-04-08 2019-04-08 -
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GlaxoSmithKline

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8 april 2019

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Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Engelsk

    Eligibility criteria

    1 Formulär  
    1. StudyEvent: ODM
      1. Eligibility criteria
    Administrative data
    Beskrivning

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Beskrivning

    Subject No.

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Beskrivning

    Panel ID

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    Is the subject a healthy, male or female subject between 18 and 50 years of age (both inclusive)?
    Beskrivning

    Healhty, Sex, Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3898900
    UMLS CUI [2]
    C0079399
    UMLS CUI [3]
    C0001779
    Is the subject's body mass index of 19 to 29 kg/m^2, with a body weight >= 50 kg?
    Beskrivning

    BMI and weight

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    UMLS CUI [2]
    C0005910
    Is the subject healthy as judged by responsible physician and no abnormality identified on the clinical examination?
    Beskrivning

    A subject with a clinical abnormality may be included only if the Principal Investigator, in agreement with the Sponsor, considers that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1708335
    UMLS CUI [1,2]
    C0855737
    Is the subject healthy as judged by resposible physician and no abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination?
    Beskrivning

    Subjects with laboratory values outside the reference range for this age group will only be included if the Principal Investigator, in agreement with the Sponsor, considers that such findings will not introduce additional risk factors.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1708335
    UMLS CUI [1,2]
    C0438214
    Is the 12-lead ECG at the pre-study screening normal?
    Beskrivning

    Normal 12-lead ECG

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0459422
    Does the subject have normal systolic (100-140 mmHg) and diastolic (<90 mmHg) blood pressure (semi-supine) at prestudy screening?
    Beskrivning

    Normal blood pressure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0277882
    UMLS CUI [2]
    C0277887
    Does the subject give a written informed consent prior to admission to the study?
    Beskrivning

    Written informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    1. Does the subject have a 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?
    Beskrivning

    Adverse reaction to study drug

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0559546
    UMLS CUI [1,2]
    C0241889
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0241889
    2. Does the subject have a history or presence of clinically significant cardiovascular, neurological, psychiatric, haemotological or renal abnormalities?
    Beskrivning

    Abnormality of organs or blood

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0243050
    UMLS CUI [2]
    C0027765
    UMLS CUI [3]
    C0004936
    UMLS CUI [4]
    C0475182
    UMLS CUI [5]
    C0151746
    3. Does the subject have a history of postural hypotension or faints?
    Beskrivning

    Postural hypotension or faints

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020651
    UMLS CUI [2]
    C0039070
    4. Does the subject have a 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?
    Beskrivning

    Gastrointestinal, hepatic or renal disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0017178
    UMLS CUI [2]
    C0023895
    UMLS CUI [3]
    C0022658
    UMLS CUI [4]
    C1512073
    5. Has the subject received prescribed medication (including the oral contraceptive pill and hormone replacement therapy) within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject's safety?
    Beskrivning

    Subjects who have taken OTC medication (apart from CYP1A2 medications, see below) may still be entered into the study, if, in the opinion of the Principal/Co-investigator in agreement with the Sponsor, the medication received will not interfere with the study procedures or compromise subject's safety.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3166216
    UMLS CUI [1,2]
    C0687133
    UMLS CUI [2,1]
    C0013231
    UMLS CUI [2,2]
    C0687133
    6. Has the subject withdrawn, introduced, or changed the dose of any drug known to substantially inhibit CYP 1A2 (e.g., ciprofloxacin, fluvoxarnine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing?
    Beskrivning

    Drugs with effect on CYP1A2

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1827490
    UMLS CUI [2,1]
    C0919438
    UMLS CUI [2,2]
    C0207509
    7. Does the subject have an abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women?
    Beskrivning

    One unit is equivalent to half a pint of beer, one measure of spirits or one glass of wine.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0085762
    8. Has the subject participated in another clinical trial, blood donation or has the subject lost blood less than 90 days before the present study?
    Beskrivning

    Other clinical trial, blood donation or blood loss

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0679823
    UMLS CUI [1,2]
    C1516648
    UMLS CUI [2]
    C0005794
    UMLS CUI [3]
    C3163616
    9. Does the subject have a positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies?
    Beskrivning

    Hepatitis B, C or HIV antibodies

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0149708
    UMLS CUI [2]
    C0281863
    UMLS CUI [3,1]
    C2697540
    UMLS CUI [3,2]
    C0741132
    10. Is the subject pregnant and/or breast-feeding?
    Beskrivning

    Pregnant or breast-feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    UMLS CUI [2]
    C0006147
    11. Is the subject a female of child-bearing potential who is not practising a clinically accepted method of contraception such as surgical sterilisation, 1.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
    Beskrivning

    No contraception

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0445107
    UMLS CUI [1,3]
    C0700589
    12. Is the subject a female with positive urine/serum pregnancy test result at screening?
    Beskrivning

    Positive pregnancy test

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0430059
    UMLS CUI [2]
    C0425986
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    Similar models

    Eligibility criteria

    1 Formulär
    1. StudyEvent: ODM
      1. Eligibility criteria
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    Healhty, Sex, Age
    Item
    Is the subject a healthy, male or female subject between 18 and 50 years of age (both inclusive)?
    boolean
    C3898900 (UMLS CUI [1])
    C0079399 (UMLS CUI [2])
    C0001779 (UMLS CUI [3])
    BMI and weight
    Item
    Is the subject's body mass index of 19 to 29 kg/m^2, with a body weight >= 50 kg?
    boolean
    C1305855 (UMLS CUI [1])
    C0005910 (UMLS CUI [2])
    Physical examination normal
    Item
    Is the subject healthy as judged by responsible physician and no abnormality identified on the clinical examination?
    boolean
    C1708335 (UMLS CUI [1,1])
    C0855737 (UMLS CUI [1,2])
    Normal laboratory parameters
    Item
    Is the subject healthy as judged by resposible physician and no abnormality revealed by the clinical laboratory parameters examination at the pre-study medical examination?
    boolean
    C1708335 (UMLS CUI [1,1])
    C0438214 (UMLS CUI [1,2])
    Normal 12-lead ECG
    Item
    Is the 12-lead ECG at the pre-study screening normal?
    boolean
    C0430456 (UMLS CUI [1,1])
    C0459422 (UMLS CUI [1,2])
    Normal blood pressure
    Item
    Does the subject have normal systolic (100-140 mmHg) and diastolic (<90 mmHg) blood pressure (semi-supine) at prestudy screening?
    boolean
    C0277882 (UMLS CUI [1])
    C0277887 (UMLS CUI [2])
    Written informed consent
    Item
    Does the subject give a written informed consent prior to admission to the study?
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    Adverse reaction to study drug
    Item
    1. Does the subject have a 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?
    boolean
    C0559546 (UMLS CUI [1,1])
    C0241889 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0241889 (UMLS CUI [2,2])
    Abnormality of organs or blood
    Item
    2. Does the subject have a history or presence of clinically significant cardiovascular, neurological, psychiatric, haemotological or renal abnormalities?
    boolean
    C0243050 (UMLS CUI [1])
    C0027765 (UMLS CUI [2])
    C0004936 (UMLS CUI [3])
    C0475182 (UMLS CUI [4])
    C0151746 (UMLS CUI [5])
    Postural hypotension or faints
    Item
    3. Does the subject have a history of postural hypotension or faints?
    boolean
    C0020651 (UMLS CUI [1])
    C0039070 (UMLS CUI [2])
    Gastrointestinal, hepatic or renal disease
    Item
    4. Does the subject have a 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?
    boolean
    C0017178 (UMLS CUI [1])
    C0023895 (UMLS CUI [2])
    C0022658 (UMLS CUI [3])
    C1512073 (UMLS CUI [4])
    Subject's medication
    Item
    5. Has the subject received prescribed medication (including the oral contraceptive pill and hormone replacement therapy) within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, which in the opinion of the Principal Investigator may interfere with the study procedures or compromise a subject's safety?
    boolean
    C3166216 (UMLS CUI [1,1])
    C0687133 (UMLS CUI [1,2])
    C0013231 (UMLS CUI [2,1])
    C0687133 (UMLS CUI [2,2])
    Drugs with effect on CYP1A2
    Item
    6. Has the subject withdrawn, introduced, or changed the dose of any drug known to substantially inhibit CYP 1A2 (e.g., ciprofloxacin, fluvoxarnine, cimetidine, ethinyloestradiol) or induce CYP1A2 (e.g., tobacco, omeprazole) within 7 days prior to first day of dosing?
    boolean
    C1827490 (UMLS CUI [1])
    C0919438 (UMLS CUI [2,1])
    C0207509 (UMLS CUI [2,2])
    Alcohol abuse
    Item
    7. Does the subject have an abuse of alcohol, defined as an average weekly intake of greater than 21 units or an average daily intake greater than 3 units for men; greater than 14 units per week or greater than 2 units per day for women?
    boolean
    C0085762 (UMLS CUI [1])
    Other clinical trial, blood donation or blood loss
    Item
    8. Has the subject participated in another clinical trial, blood donation or has the subject lost blood less than 90 days before the present study?
    boolean
    C0679823 (UMLS CUI [1,1])
    C1516648 (UMLS CUI [1,2])
    C0005794 (UMLS CUI [2])
    C3163616 (UMLS CUI [3])
    Hepatitis B, C or HIV antibodies
    Item
    9. Does the subject have a positive pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies?
    boolean
    C0149708 (UMLS CUI [1])
    C0281863 (UMLS CUI [2])
    C2697540 (UMLS CUI [3,1])
    C0741132 (UMLS CUI [3,2])
    Pregnant or breast-feeding
    Item
    10. Is the subject pregnant and/or breast-feeding?
    boolean
    C0549206 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    No contraception
    Item
    11. Is the subject a female of child-bearing potential who is not practising a clinically accepted method of contraception such as surgical sterilisation, 1.U.D., diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (i.e., Norplant)?
    boolean
    C3831118 (UMLS CUI [1,1])
    C0445107 (UMLS CUI [1,2])
    C0700589 (UMLS CUI [1,3])
    Positive pregnancy test
    Item
    12. Is the subject a female with positive urine/serum pregnancy test result at screening?
    boolean
    C0430059 (UMLS CUI [1])
    C0425986 (UMLS CUI [2])
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