ID

26627

Description

Study ID: 101468/199 Clinical Study ID: 101468/199 Study Title: An open label study conducted in healthy volunteers to characterize the pharmacokinetics of a new unmarketed formulation of ropinirole 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 Documentation part (Visit Description): Dose Level 2, Day 10

Mots-clés

Versions (2)
  1. 22/10/2017 22/10/2017 -
  2. 22/10/2017 22/10/2017 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

22 octobre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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Pharmacokinetics of a new unmarketed formulation of ropinirole Day 10 101468/199

Anglais

Dose Level 2, Day 10

1 Formulaires  
  1. StudyEvent: ODM
    1. Dose Level 2, Day 10
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0031809
Timepoint of Vital signs
Description

Timepoint of Vital signs

Type de données

integer

Alias
UMLS CUI [1]
C0518766
Date
Description

Of Examination

Type de données

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time
Description

Of Examination

Type de données

text

Alias
UMLS CUI [1]
C0439564
Actual time
Description

of Examination

Type de données

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood pressure
Description

Systolic Blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Description

Diastolic Blood pressure

Type de données

integer

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Description

Subject Position

Type de données

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0244821
Investigational Product
Description

Investigational Product

Type de données

integer

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2]
C0244821
Date of Dose
Description

Date of Dose

Type de données

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
Time of Dose
Description

Time of Dose

Type de données

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0040223
Dose
Description

Dose

Type de données

float

Unités de mesure
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
Units
Description

Units

Type de données

text

Alias
UMLS CUI [1,1]
C1519795
UMLS CUI [1,2]
C0304229
Route
Description

Route

Type de données

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0304229
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Description

Treatment confirmation

Type de données

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
If No, record reason(s)
Description

Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

Type de données

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0392360
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
UMLS CUI-2
C0022885
Date sample taken for Pregnancy Test
Description

Date of Pregnancy Test

Type de données

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy Test Result
Description

If 'Positive', withdraw the subject from the study.

Type de données

integer

Alias
UMLS CUI [1]
C0427777
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Similar models

Dose Level 2, Day 10

1 Formulaires
  1. StudyEvent: ODM
    1. Dose Level 2, Day 10
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
Timepoint of Vital signs
integer
C0518766 (UMLS CUI [1])
Timepoint of Vital signs
Code List
Timepoint of Vital signs
CL Item
Pre-dose  (1)
CL Item
+4 hrs (2)
CL Item
Unscheduled (3)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Planned Relative Time
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject Position
Code List
Subject Position
CL Item
Supine (1)
CL Item
Standing (2)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
C0244821 (UMLS CUI-2)
Item
Investigational Product
integer
C0304229 (UMLS CUI [1])
C0244821 (UMLS CUI [2])
Investigational Product
Code List
Investigational Product
CL Item
Ropinirole (1)
Date of Dose
Item
Date of Dose
date
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time of Dose
Item
Time of Dose
time
C0304229 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Units
Item
Units
text
C1519795 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Route
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
Treatment confirmation
Item
Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Treatment confirmation
Item
If No, record reason(s)
text
C0750484 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0392360 (UMLS CUI [2])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
Date of Pregnancy Test
Item
Date sample taken for Pregnancy Test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy Test Result
integer
C0427777 (UMLS CUI [1])
Pregnancy Test Result
Code List
Pregnancy Test Result
CL Item
Positive (1)
CL Item
Negative (2)
CL Item
Not applicable (Not of childbearing potential) (3)
Retour au début de la page 

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