ID

25361

Beskrivning

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

Nyckelord

  1. 2017-09-02 2017-09-02 -
  2. 2019-06-21 2019-06-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

2 september 2017

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

PK Sampling Week 1 Day 1 Ropinirole Restless Legs Syndrome 101468/201

PK Sampling Week 1 Day 1

PK SAMPLING
Beskrivning

PK SAMPLING

Alias
UMLS CUI-1
C0022877
Subject number
Beskrivning

Subject number

Datatyp

integer

Alias
UMLS CUI [1]
C2348585
Date
Beskrivning

Date

Datatyp

date

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Date
Beskrivning

Date

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

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

Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Beskrivning

Sample taken

Datatyp

boolean

Alias
UMLS CUI [1]
C0200345
Comments
Beskrivning

Comments

Datatyp

text

Alias
UMLS CUI [1]
C0947611

Similar models

PK Sampling Week 1 Day 1

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial