ID

36030

Description

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 vital signs form. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Keywords

Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 9, 2019

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License

Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

English

Vital Signs

1 forms  
  1. StudyEvent: ODM
    1. Vital Signs
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1320303
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Planned relative time for predose day 1
Description

Only for predose day 1.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0518766
Planned relative time for day 1
Description

Only for day 1.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0518766
Planned relative time for day 2
Description

Only for day 2.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0518766
Date of vital signs
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C2826644
Time of vital signs
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C2826762
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
Pulse
Description

Pulse

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0232117
bpm
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Vital Signs

1 forms
  1. StudyEvent: ODM
    1. Vital Signs
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 1 day 2 (2)
CL Item
Session 2 day 1  (3)
CL Item
Session 2 day 2 (4)
CL Item
Session 3 day 1 (5)
CL Item
Session 3 day 2 (6)
CL Item
Session 4 day 1 (7)
CL Item
Session 4 day 2 (8)
CL Item
Session 5 day 1 (9)
CL Item
Session 5 day 2 (10)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Item
Planned relative time for predose day 1
integer
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned relative time for predose day 1
Code List
Planned relative time for predose day 1
CL Item
Pre/Semi-supine  (1)
CL Item
Pre/Standing 1 (2)
CL Item
Pre/Semi-supine 2  (3)
CL Item
Pre/Standing 2  (4)
CL Item
Pre/Semi-supine 3  (5)
CL Item
Pre/Standing 3  (6)
CL Item
Pre/Semi-supine 4 (7)
CL Item
Pre/Standing 4  (8)
CL Item
Pre/Semi-supine 5  (9)
CL Item
Pre/Standing 5  (10)
CL Item
Pre/Semi-supine 6  (11)
CL Item
Pre/Standing 6 (12)
Item
Planned relative time for day 1
integer
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned relative time for predose day 1
Code List
Planned relative time for day 1
CL Item
+ 1 h/Semi-supine  (1)
CL Item
+ 1 h/Standing  (2)
CL Item
+ 2 h/Semi-supine  (3)
CL Item
+ 2 h/Standing  (4)
CL Item
+3 h/Semi-supine  (5)
CL Item
+3 h/Standing  (6)
CL Item
+4 h/Semi-supine  (7)
CL Item
+4 h/Standing  (8)
CL Item
+5 h/Semi-supine  (9)
CL Item
+5 h/Standing  (10)
CL Item
+6 h/Semi-supine  (11)
CL Item
+6 h/Standing (12)
Item
Planned relative time for day 2
integer
C0439564 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Planned relative time for predose day 1
Code List
Planned relative time for day 2
CL Item
+ 16 h/Semi-supine  (1)
CL Item
+ 16 h/Standing  (2)
CL Item
+ 24 h/Semi-supine  (3)
CL Item
+ 24 h/Standing (4)
Date of vital signs
Item
Date of vital signs
date
C2826644 (UMLS CUI [1])
Time of vital signs
Item
Time of vital signs
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood pressure
integer
C0428883 (UMLS CUI [1])
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
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