ID

25486

Beschrijving

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy 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 : Restless Legs Syndrome

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  1. 04-09-17 04-09-17 -
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GlaxoSmithKline

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4 september 2017

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Creative Commons BY-NC 3.0
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screening inclusion/exclusion criteria PK and tolerability of ropinirole as 5 new formulations 101468/197

Engels

screening inclusion/exclusion criteria PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Focus Panel ID
Beschrijving

focus panel

Datatype

integer

Alias
UMLS CUI [1]
C3846158
Patient No
Beschrijving

patient number

Datatype

integer

Alias
UMLS CUI [1]
C1830427
Date
Beschrijving

date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Is the subject healthy, non-smoking, and between 18 and 50 years of age?
Beschrijving

subject healthy, non-smoker, adult

Datatype

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0337672
UMLS CUI [3]
C0001675
Does the subject have a body mass index in the range 19-29 kg/m², with a body weight of at least 50 kg?
Beschrijving

BMI, weight

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0005910
Does the subject have no abnormality on clinical examination or has the Principal Investigator considered, in agreement with the sponsor, that any abnormality will not introduce additional risk factors and will not interfere with the study procedes?
Beschrijving

abnormality in clinical examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C1456356
Does the subject have no abnormality revealed by the clinical chemistry or haematology examination at the pre-study medical examination or has the Principal Investigator considered, in agreement with the sponsor, that the findings of laboratory values outside the reference range will not introduce additional risk factors?
Beschrijving

laboratory finding

Datatype

boolean

Alias
UMLS CUI [1]
C0587081
Was the subject's 12-lead ECG normal at the pre-study examination?
Beschrijving

ECG normal

Datatype

boolean

Alias
UMLS CUI [1]
C0522054
Was the subject's blood pressure (in semi-supine position) normal at the pre-study examination (systolic blood pressure within 100-140 mmHg and diastolic blood pressure below 90 mmHg)?
Beschrijving

blood pressure supine position

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
Has the subject given his written consent prior to admission to the study?
Beschrijving

written consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Investigator's signature
Beschrijving

investigator's signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

date

Datatype

date

Alias
UMLS CUI [1]
C0011008
Exclusion criteria
Beschrijving

Exclusion criteria

Alias
UMLS CUI-1
C0680251
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?
Beschrijving

drug incompatibility to study drug

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013184
UMLS CUI [1,2]
C0013230
Does the subject have a history or known presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities?
Beschrijving

cardiovascular, neurological, psychiatric, haematologial or renal abnormality

Datatype

boolean

Alias
UMLS CUI [1]
C0243050
UMLS CUI [2]
C0027765
UMLS CUI [3]
C0004936
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0022658
Does the subject have a history of postural hypotension or faints?
Beschrijving

postural hypotension or faint

Datatype

boolean

Alias
UMLS CUI [1]
C0020651
UMLS CUI [2]
C0039070
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?
Beschrijving

gastrointestinal, hepatic or renal disease

Datatype

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0022658
Has the subject received prescribed medication (including hormone replacement therapy) within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, with exception of hormone contraception and paracetamol?
Beschrijving

prescribed medication or OTC medicine

Datatype

boolean

Alias
UMLS CUI [1]
C3166216
UMLS CUI [2]
C0013231
Is the subject known to drink alcohol regularly, defined as an average weekly intake of greater than 14 units or an average daily intake greater than 2 units for men ; greater than 7 units per week or greater than I unit per day for women? One unit is equivalent to half a bottle of beer, one measure of spirits or one glass of wine.
Beschrijving

alcohol abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0085762
Did the subject participate in another clinical trial, blood donation or blood loss less than 90 days before the present study?
Beschrijving

study participation or blood donation or blood loss

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0005794
UMLS CUI [3]
C3163616
Is the pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies positive?
Beschrijving

hepatitis B, hepatitis C or HIV positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019682
Is the subject pregnant and/or breast-feeding?
Beschrijving

pregnancy or breast-feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Is the subject female and of child-bearing potential and not practising a clincally accepted method of contraception such as surgical sterilisation, I.U.D., diaphragm in conjunction with spermacidal foam and concom on the male partner, oral contraceptive pill or systemic contraception (i.e., Norplant)?
Beschrijving

child bearing potential, contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0015895
UMLS CUI [2]
C0700589
Is the serum hCG test result positive (at screening or prior to dosing for each dosing session)?
Beschrijving

hCG positive

Datatype

boolean

Alias
UMLS CUI [1]
C0428402
Investigator's signature
Beschrijving

investigator's signature

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date
Beschrijving

date

Datatype

date

Alias
UMLS CUI [1]
C0011008
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Similar models

screening inclusion/exclusion criteria PK and tolerability of ropinirole as 5 new formulations 101468/197

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
focus panel
Item
Focus Panel ID
integer
C3846158 (UMLS CUI [1])
patient number
Item
Patient No
integer
C1830427 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
subject healthy, non-smoker, adult
Item
Is the subject healthy, non-smoking, and between 18 and 50 years of age?
boolean
C3898900 (UMLS CUI [1])
C0337672 (UMLS CUI [2])
C0001675 (UMLS CUI [3])
BMI, weight
Item
Does the subject have a body mass index in the range 19-29 kg/m², with a body weight of at least 50 kg?
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
abnormality in clinical examination
Item
Does the subject have no abnormality on clinical examination or has the Principal Investigator considered, in agreement with the sponsor, that any abnormality will not introduce additional risk factors and will not interfere with the study procedes?
boolean
C1704258 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
laboratory finding
Item
Does the subject have no abnormality revealed by the clinical chemistry or haematology examination at the pre-study medical examination or has the Principal Investigator considered, in agreement with the sponsor, that the findings of laboratory values outside the reference range will not introduce additional risk factors?
boolean
C0587081 (UMLS CUI [1])
ECG normal
Item
Was the subject's 12-lead ECG normal at the pre-study examination?
boolean
C0522054 (UMLS CUI [1])
blood pressure supine position
Item
Was the subject's blood pressure (in semi-supine position) normal at the pre-study examination (systolic blood pressure within 100-140 mmHg and diastolic blood pressure below 90 mmHg)?
boolean
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
written consent
Item
Has the subject given his written consent prior to admission to the study?
boolean
C0021430 (UMLS CUI [1])
investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
drug incompatibility to study drug
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
C0013184 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
cardiovascular, neurological, psychiatric, haematologial or renal abnormality
Item
Does the subject have a history or known presence of clinically significant cardiovascular, neurological, psychiatric, haematological or renal abnormalities?
boolean
C0243050 (UMLS CUI [1])
C0027765 (UMLS CUI [2])
C0004936 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
postural hypotension or faint
Item
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
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])
prescribed medication or OTC medicine
Item
Has the subject received prescribed medication (including hormone replacement therapy) within 14 days or over-the-counter (OTC) medicine within 7 days before the first dosing day, with exception of hormone contraception and paracetamol?
boolean
C3166216 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
alcohol abuse
Item
Is the subject known to drink alcohol regularly, defined as an average weekly intake of greater than 14 units or an average daily intake greater than 2 units for men ; greater than 7 units per week or greater than I unit per day for women? One unit is equivalent to half a bottle of beer, one measure of spirits or one glass of wine.
boolean
C0085762 (UMLS CUI [1])
study participation or blood donation or blood loss
Item
Did the subject participate in another clinical trial, blood donation or blood loss less than 90 days before the present study?
boolean
C2348568 (UMLS CUI [1])
C0005794 (UMLS CUI [2])
C3163616 (UMLS CUI [3])
hepatitis B, hepatitis C or HIV positive
Item
Is the pre-study screening result for hepatitis B surface antigen, hepatitis C antibody or HIV-1/2 antibodies positive?
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
pregnancy or breast-feeding
Item
Is the subject pregnant and/or breast-feeding?
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
child bearing potential, contraception
Item
Is the subject female and of child-bearing potential and not practising a clincally accepted method of contraception such as surgical sterilisation, I.U.D., diaphragm in conjunction with spermacidal foam and concom on the male partner, oral contraceptive pill or systemic contraception (i.e., Norplant)?
boolean
C0015895 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
hCG positive
Item
Is the serum hCG test result positive (at screening or prior to dosing for each dosing session)?
boolean
C0428402 (UMLS CUI [1])
investigator's signature
Item
Investigator's signature
text
C2346576 (UMLS CUI [1])
date
Item
Date
date
C0011008 (UMLS CUI [1])
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