0 Ratings
ID

26114

Description

Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Screening

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Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

GlaxoSmithKline

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October 9, 2017

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Creative Commons BY-NC 3.0
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    Dose strength equivalence of ropinirole CR in healthy adults Screening 101468/219

    English

    Screening Dose strength equivalence of ropinirole CR in healthy adults 101468/219

    1 forms  
    Demography
    Description

    Demography

    Alias
    UMLS CUI-1
    C0011298
    UMLS CUI-2
    C1710477
    Date of birth
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Gender
    Description

    Gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Race
    Description

    Race

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0034510
    If other race, please specify
    Description

    Specification of other race

    Data type

    text

    Alias
    UMLS CUI [1]
    C0034510
    Height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body Mass Index
    Description

    Body Mass Index

    Data type

    float

    Measurement units
    • kg/m2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m2
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI-1
    C1512693
    UMLS CUI-2
    C1516637
    Is the subject a healthy, non-smoking, non vegetarian male or female between 18 and 50 years of age (inclusive)?
    Description

    health status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018759
    UMLS CUI [2]
    C1512693
    Does the subject have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
    Description

    body mass index

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1305855
    UMLS CUI [2]
    C1512693
    Does the subject show a normal 12-lead ECG at Screening?
    Description

    12-lead ECG

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430456
    UMLS CUI [2]
    C1512693
    Does the subject have normal systolic (100-140mmHg) and diastolic (<90mmHg) blood pressure (supine) at Screening?
    Description

    blood pressure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005823
    UMLS CUI [2]
    C1512693
    Has the subject given written informed consent prior to any specific study procedures being performed?
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C1512693
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI-1
    C0680251
    UMLS CUI-2
    C1516637
    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?
    Description

    hypersensitivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013182
    UMLS CUI [2]
    C0680251
    Does the subject have a history or presence of clinically significant cardiovascular, neurological, psychiatric, haemotological or renal abnormalities?
    Description

    medical history

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0262926
    UMLS CUI [2]
    C0680251
    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?
    Description

    medical history

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0262926
    UMLS CUI [2]
    C0680251
    Has the patient received prescribed medication with 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, which in the opinion of the investigator may interfere with the study procedures or compromise the subject’s safety? (Subject’s who have taken OTC medication may still be entered in the study, if, in the opinion of the Investigator in agreement with the sponsor, the medication will not interfere with the study procedures or compromise the subject’s safety)
    Description

    prescribed medication

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3166216
    UMLS CUI [2]
    C0680251
    Does the patient meet DSM-IV criteria for substance ’abuse’ (alcohol or drugs) or substance ’dependence’ within 6 months prior to screening? (abuse of alcohol defined as an intake of grater than 3 units per day or 21 units per week for male or 2 units per day or 14 units per week for females. (one unit is equivalent to half pint of beer, one measure of sprits or one small glass of wine)
    Description

    substance abuse

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0680251
    Has the subject participated in another clinical trial within the last 90 days?
    Description

    clinical trial

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0008976
    UMLS CUI [2]
    C0680251
    Has the subject given a blood donation or had significant blood loss less than 90 days before the present study?
    Description

    blood donation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0005794
    UMLS CUI [2]
    C0680251
    Has the subject had a positive hepatitis B antigen, hepatitis C antibody or HIV serology at screening?
    Description

    HIV serology

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0744862
    UMLS CUI [1,2]
    C0019699
    UMLS CUI [3]
    C0680251
    Is the subject a female who has a positive urine HCG result or is lactating at screening?
    Description

    pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0680251
    Is the subject a female who is on hormone replacement therapy (HRT) or using a contraceptive pill?
    Description

    contraception

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    UMLS CUI [2]
    C0680251
    Is the subject a female of child bearing potential who is intending to become pregnant or is not willing to avoid pregnancy by means of a highly effective method of birth control (failure rate <1% per year when used consistently and correctly)?
    Description

    pregnant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0680251
    Is the subject a male who is intending to father a child or not willing to use condoms (in case of neither contraceptive pill or IUD use in female partners) during the study from prior to dosing to follow-up?
    Description

    contraception

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    UMLS CUI [2]
    C0680251
    Has the subject had a positive urine drugs of abuse test at screening?
    Description

    positive urine drugs of abuse test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0202274
    UMLS CUI [2]
    C0680251
    Has the subject had a withdrawal, introduction, or change in dose of any drug known to substantially inhibit or induce CYP1A2 within 7 days prior to enrolment?
    Description

    CYP1A2

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1827504
    UMLS CUI [1,2]
    C1827490
    UMLS CUI [2]
    C0680251
    Does the subject have an abnormality on clinical chemistry of haematology examination at screening? (Subject’s with laboratory values outside the reference range for this age group will only be included if the Investigator considers that such findings will not introduce additional risk factors).
    Description

    abnormality on clinical chemistry or haematology

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347783
    UMLS CUI [2]
    C0474523
    UMLS CUI [3]
    C0680251
    Does the subject have an abnormality on clinical examination? A subject may be included if the investigator considers that this will not introduce additional risk factors and will not interfere with the study procedures.
    Description

    clinical examination

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031809
    UMLS CUI [2]
    C0680251
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    Similar models

    Screening Dose strength equivalence of ropinirole CR in healthy adults 101468/219

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    C1710477 (UMLS CUI-2)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Gender
    integer
    C0079399 (UMLS CUI [1])
    Gender
    Code List
    Gender
    CL Item
    Male (1)
    CL Item
    Female (2)
    Item
    Race
    integer
    C0034510 (UMLS CUI [1])
    Race
    Code List
    Race
    CL Item
    White (1)
    CL Item
    Black (2)
    CL Item
    Oriental (3)
    CL Item
    Other (specify below) (4)
    Specification of other race
    Item
    If other race, please specify
    text
    C0034510 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body Mass Index
    Item
    Body Mass Index
    float
    C1305855 (UMLS CUI [1])
    Item Group
    Inclusion Criteria
    C1512693 (UMLS CUI-1)
    C1516637 (UMLS CUI-2)
    health status
    Item
    Is the subject a healthy, non-smoking, non vegetarian male or female between 18 and 50 years of age (inclusive)?
    boolean
    C0018759 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    body mass index
    Item
    Does the subject have a body mass index (BMI = weight kg/height m2) within the range 19 to 29 kg.m-2?
    boolean
    C1305855 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    12-lead ECG
    Item
    Does the subject show a normal 12-lead ECG at Screening?
    boolean
    C0430456 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    blood pressure
    Item
    Does the subject have normal systolic (100-140mmHg) and diastolic (<90mmHg) blood pressure (supine) at Screening?
    boolean
    C0005823 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    informed consent
    Item
    Has the subject given written informed consent prior to any specific study procedures being performed?
    boolean
    C0021430 (UMLS CUI [1])
    C1512693 (UMLS CUI [2])
    Item Group
    Exclusion Criteria
    C0680251 (UMLS CUI-1)
    C1516637 (UMLS CUI-2)
    hypersensitivity
    Item
    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
    C0013182 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    medical history
    Item
    Does the subject have a history or presence of clinically significant cardiovascular, neurological, psychiatric, haemotological or renal abnormalities?
    boolean
    C0262926 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    medical history
    Item
    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
    C0262926 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    prescribed medication
    Item
    Has the patient received prescribed medication with 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, which in the opinion of the investigator may interfere with the study procedures or compromise the subject’s safety? (Subject’s who have taken OTC medication may still be entered in the study, if, in the opinion of the Investigator in agreement with the sponsor, the medication will not interfere with the study procedures or compromise the subject’s safety)
    boolean
    C3166216 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    substance abuse
    Item
    Does the patient meet DSM-IV criteria for substance ’abuse’ (alcohol or drugs) or substance ’dependence’ within 6 months prior to screening? (abuse of alcohol defined as an intake of grater than 3 units per day or 21 units per week for male or 2 units per day or 14 units per week for females. (one unit is equivalent to half pint of beer, one measure of sprits or one small glass of wine)
    boolean
    C0038586 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    clinical trial
    Item
    Has the subject participated in another clinical trial within the last 90 days?
    boolean
    C0008976 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    blood donation
    Item
    Has the subject given a blood donation or had significant blood loss less than 90 days before the present study?
    boolean
    C0005794 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    HIV serology
    Item
    Has the subject had a positive hepatitis B antigen, hepatitis C antibody or HIV serology at screening?
    boolean
    C0744862 (UMLS CUI [1,1])
    C0019699 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [3])
    pregnancy
    Item
    Is the subject a female who has a positive urine HCG result or is lactating at screening?
    boolean
    C0032961 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    contraception
    Item
    Is the subject a female who is on hormone replacement therapy (HRT) or using a contraceptive pill?
    boolean
    C0700589 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    pregnant
    Item
    Is the subject a female of child bearing potential who is intending to become pregnant or is not willing to avoid pregnancy by means of a highly effective method of birth control (failure rate <1% per year when used consistently and correctly)?
    boolean
    C0032961 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    contraception
    Item
    Is the subject a male who is intending to father a child or not willing to use condoms (in case of neither contraceptive pill or IUD use in female partners) during the study from prior to dosing to follow-up?
    boolean
    C0700589 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    positive urine drugs of abuse test
    Item
    Has the subject had a positive urine drugs of abuse test at screening?
    boolean
    C0202274 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
    CYP1A2
    Item
    Has the subject had a withdrawal, introduction, or change in dose of any drug known to substantially inhibit or induce CYP1A2 within 7 days prior to enrolment?
    boolean
    C1827504 (UMLS CUI [1,1])
    C1827490 (UMLS CUI [1,2])
    C0680251 (UMLS CUI [2])
    abnormality on clinical chemistry or haematology
    Item
    Does the subject have an abnormality on clinical chemistry of haematology examination at screening? (Subject’s with laboratory values outside the reference range for this age group will only be included if the Investigator considers that such findings will not introduce additional risk factors).
    boolean
    C2347783 (UMLS CUI [1])
    C0474523 (UMLS CUI [2])
    C0680251 (UMLS CUI [3])
    clinical examination
    Item
    Does the subject have an abnormality on clinical examination? A subject may be included if the investigator considers that this will not introduce additional risk factors and will not interfere with the study procedures.
    boolean
    C0031809 (UMLS CUI [1])
    C0680251 (UMLS CUI [2])
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