ID

26114

Beschrijving

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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  1. 09-10-17 09-10-17 -
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Dose strength equivalence of ropinirole CR in healthy adults Screening 101468/219

Engels

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

1 Formulieren  
Demography
Beschrijving

Demography

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

Date of birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschrijving

Gender

Datatype

integer

Alias
UMLS CUI [1]
C0079399
Race
Beschrijving

Race

Datatype

integer

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

Specification of other race

Datatype

text

Alias
UMLS CUI [1]
C0034510
Height
Beschrijving

Height

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

Weight

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body Mass Index
Beschrijving

Body Mass Index

Datatype

float

Maateenheden
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Inclusion Criteria
Beschrijving

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)?
Beschrijving

health status

Datatype

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?
Beschrijving

body mass index

Datatype

boolean

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

12-lead ECG

Datatype

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?
Beschrijving

blood pressure

Datatype

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?
Beschrijving

informed consent

Datatype

boolean

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

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?
Beschrijving

hypersensitivity

Datatype

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?
Beschrijving

medical history

Datatype

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?
Beschrijving

medical history

Datatype

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)
Beschrijving

prescribed medication

Datatype

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)
Beschrijving

substance abuse

Datatype

boolean

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

clinical trial

Datatype

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?
Beschrijving

blood donation

Datatype

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?
Beschrijving

HIV serology

Datatype

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?
Beschrijving

pregnancy

Datatype

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?
Beschrijving

contraception

Datatype

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)?
Beschrijving

pregnant

Datatype

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?
Beschrijving

contraception

Datatype

boolean

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

positive urine drugs of abuse test

Datatype

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?
Beschrijving

CYP1A2

Datatype

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).
Beschrijving

abnormality on clinical chemistry or haematology

Datatype

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.
Beschrijving

clinical examination

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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