ID

36091

Beschreibung

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.

Stichworte

Versionen (2)
  1. 15.04.19 15.04.19 -
  2. 15.04.19 15.04.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

15. April 2019

DOI

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

Englisch

Drug Screening and Alcohol Breath Test for screening

1 Formulare  
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschreibung

Subject No.:

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschreibung

Panel ID

Datentyp

text

Alias
UMLS CUI [1]
C3846158
Visit Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Drug Screening
Beschreibung

Drug Screening

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

00:00-23:59

Datentyp

time

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

00:00-23:59

Datentyp

time

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

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

Datentyp

text

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

Type of drug

Datentyp

text

Alias
UMLS CUI [1]
C0457591
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Alcohol breath test
Beschreibung

Alcohol breath test

Alias
UMLS CUI-1
C0202306
Exact time of test
Beschreibung

00:00-23:59

Datentyp

time

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

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

Datentyp

text

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

Drug Screening and Alcohol Breath Test for screening

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Contra-indicated drugs detected
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])
Result of Alcohol breath test
Code List
Result of Alcohol breath test
CL Item
Positive (P)
CL Item
Negative (N)
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