ID

25361

Description

Study part: PK Sampling Week 1 Day 1. A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. 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. Study ID: 101468/201. Clinical Study ID: 101468/201

Keywords

Versions (2)
  1. 9/2/17 9/2/17 -
  2. 6/21/19 6/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 2, 2017

DOI

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License

Creative Commons BY-NC 3.0
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PK Sampling Week 1 Day 1 Ropinirole Restless Legs Syndrome 101468/201

English

PK Sampling Week 1 Day 1

1 forms  
PK SAMPLING
Description

PK SAMPLING

Alias
UMLS CUI-1
C0022877
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Time relative to start of dose- Pre-dose- Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +0.25 hr - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +0.5 hr - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +0.75 hr - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +1 hr - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +2 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +3 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +4 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +6 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +8 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +10 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Date
Description

Date

Data type

date

Alias
UMLS CUI [1]
C0011008
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +12 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +14 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +16 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Time relative to start of dose- +24 hrs - Actual time
Description

Time

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

PK Sampling Week 1 Day 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
PK SAMPLING
C0022877 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Time
Item
Time relative to start of dose- Pre-dose- Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +0.25 hr - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +0.5 hr - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +0.75 hr - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +1 hr - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +2 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +3 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +4 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +6 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +8 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +10 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +12 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +14 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +16 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Time
Item
Time relative to start of dose- +24 hrs - Actual time
time
C0040223 (UMLS CUI [1])
Sample taken
Item
Sample taken
boolean
C0200345 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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