ID

35977

Beschrijving

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.

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  1. 08-04-19 08-04-19 -
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GlaxoSmithKline

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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

Engels

Eligibility criteria

1 Formulieren  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschrijving

Panel ID

Datatype

text

Alias
UMLS CUI [1]
C3846158
Visit date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
Inclusion Criteria
Beschrijving

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)?
Beschrijving

Healhty, Sex, Age

Datatype

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?
Beschrijving

BMI and weight

Datatype

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?
Beschrijving

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.

Datatype

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?
Beschrijving

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.

Datatype

boolean

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

Normal 12-lead ECG

Datatype

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?
Beschrijving

Normal blood pressure

Datatype

boolean

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

Written informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

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?
Beschrijving

Adverse reaction to study drug

Datatype

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?
Beschrijving

Abnormality of organs or blood

Datatype

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?
Beschrijving

Postural hypotension or faints

Datatype

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?
Beschrijving

Gastrointestinal, hepatic or renal disease

Datatype

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?
Beschrijving

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.

Datatype

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?
Beschrijving

Drugs with effect on CYP1A2

Datatype

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?
Beschrijving

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

Datatype

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?
Beschrijving

Other clinical trial, blood donation or blood loss

Datatype

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?
Beschrijving

Hepatitis B, C or HIV antibodies

Datatype

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?
Beschrijving

Pregnant or breast-feeding

Datatype

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)?
Beschrijving

No contraception

Datatype

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?
Beschrijving

Positive pregnancy test

Datatype

boolean

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

Eligibility criteria

1 Formulieren
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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