ID

36091

Beskrivning

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 Drug Screening and Alcohol Breath Test for screening form. It has to be filled in for screening.

Nyckelord

  1. 2019-04-15 2019-04-15 -
  2. 2019-04-15 2019-04-15 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

15 april 2019

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.

Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Drug Screening and Alcohol Breath Test for screening

Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beskrivning

Subject No.:

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beskrivning

Panel ID

Datatyp

text

Alias
UMLS CUI [1]
C3846158
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Drug Screening
Beskrivning

Drug Screening

Alias
UMLS CUI-1
C0373483
Exact time of urine sampling
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
Exact time of blood sampling
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0005834
Were there any contra-indicated drugs detected?
Beskrivning

If YES, please record all the relevant contra-indicated drugs below.

Datatyp

text

Alias
UMLS CUI [1,1]
C1511790
UMLS CUI [1,2]
C1444657
UMLS CUI [1,3]
C1254351
Type of drug
Beskrivning

Type of drug

Datatyp

text

Alias
UMLS CUI [1]
C0457591
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Alcohol breath test
Beskrivning

Alcohol breath test

Alias
UMLS CUI-1
C0202306
Exact time of test
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C0429928
Result of Alcohol breath test
Beskrivning

Alcohol breath test result, tick one If POSITIVE, do not include the subject in the study.

Datatyp

text

Alias
UMLS CUI [1,1]
C0202306
UMLS CUI [1,2]
C1274040

Similar models

Drug Screening and Alcohol Breath Test for screening

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Drug Screening
C0373483 (UMLS CUI-1)
Urine sampling time
Item
Exact time of urine sampling
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blodd sampling time
Item
Exact time of blood sampling
time
C0040223 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Item
Were there any contra-indicated drugs detected?
text
C1511790 (UMLS CUI [1,1])
C1444657 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
Code List
Were there any contra-indicated drugs detected?
CL Item
Yes (Y)
CL Item
No (N)
Type of drug
Item
Type of drug
text
C0457591 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Alcohol breath test
C0202306 (UMLS CUI-1)
Time of test
Item
Exact time of test
time
C0202306 (UMLS CUI [1,1])
C0429928 (UMLS CUI [1,2])
Item
Result of Alcohol breath test
text
C0202306 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Code List
Result of Alcohol breath test
CL Item
Positive (P)
CL Item
Negative (N)

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