ID

26877

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): PK Study Session 6, Day 28

Keywords

Versions (1)
  1. 10/27/17 10/27/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 27, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Pharmacokinetics of a new unmarketed formulation of ropinirole Day 28 101468/199

English

PK Study Session 6, Day 28

1 forms  
Vital signs
Description

Vital signs

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

Timepoint of Vital signs

Data type

integer

Alias
UMLS CUI [1]
C0518766
Date of Vital Signs Examination
Description

Date of Vital Signs Examination

Data type

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Planned Relative Time of Vital signs Examination
Description

Planned Relative Time

Data type

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual time
Description

of Examination

Data type

time

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

Systolic Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood pressure
Description

Diastolic Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Description

Subject Position

Data type

integer

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

Heart rate

Data type

integer

Measurement units
  • 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

Data type

integer

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

Date of Dose

Data type

date

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

Time of Dose

Data type

time

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

Dose

Data type

float

Measurement units
  • mg/Day
Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0304229
mg/Day
Units
Description

Units

Data type

text

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

Route

Data type

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

Data type

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?

Data type

text

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0392360
Pharmacokinetics - Blood
Description

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0304229
Planned Relative Time, check one
Description

Time Relative to Dosing

Data type

integer

Alias
UMLS CUI [1]
C0439564
UMLS CUI [2]
C0005834
Date Blood Sample Taken
Description

Date Blood Sample Taken

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Time Blood Sample Taken
Description

Time Blood Sample Taken

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Blood sample taken?
Description

Blood sample taken

Data type

boolean

Alias
UMLS CUI [1]
C1277698
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Similar models

PK Study Session 6, Day 28

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 (1)
CL Item
+2 hrs (2)
CL Item
+4 hrs (3)
CL Item
+6 hrs (4)
CL Item
+12 hrs (5)
CL Item
+24 hrs (6)
CL Item
Unscheduled (7)
Date of Vital Signs Examination
Item
Date of Vital Signs Examination
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Planned Relative Time
Item
Planned Relative Time of Vital signs Examination
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
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
C0244821 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
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
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Item
Planned Relative Time, check one
integer
C0439564 (UMLS CUI [1])
C0005834 (UMLS CUI [2])
Planned Relative Time
Code List
Planned Relative Time, check one
CL Item
Pre-dose (1)
CL Item
+0.25 hrs (2)
CL Item
+0.5 hrs (3)
CL Item
+0.75 hrs (4)
CL Item
+1 hr (5)
CL Item
+2 hrs (6)
CL Item
+3 hrs (7)
CL Item
+4 hrs (8)
CL Item
+6 hrs (9)
CL Item
+8 hrs (10)
CL Item
+12 hrs (11)
CL Item
+16 hrs (12)
CL Item
+24 hrs (13)
Date Blood Sample Taken
Item
Date Blood Sample Taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time Blood Sample Taken
Item
Time Blood Sample Taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood sample taken
Item
Blood sample taken?
boolean
C1277698 (UMLS CUI [1])
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