ID

36026

Beschrijving

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.

Trefwoorden

Versies (1)
  1. 09-04-19 09-04-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

9 april 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

Investigator's Check list

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschrijving

Panel ID

Datatype

text

Alias
UMLS CUI [1]
C3846158
Investigators checklist
Beschrijving

Investigators checklist

Alias
UMLS CUI-1
C1707357
UMLS CUI-2
C0008961
Check all Adverse Event forms are up to date and complete
Beschrijving

Tick when done

Datatype

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0205197
Check that the Concomitant Medication form is up to date
Beschrijving

Tick when done

Datatype

boolean

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0920316
UMLS CUI [1,3]
C0237400
Check that all appropriate pages are signed (thus indicating completion) and dated
Beschrijving

Tick when done

Datatype

boolean

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C1519316
Check that laboratory results are included
Beschrijving

Tick when done

Datatype

boolean

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C1254595
UMLS CUI [1,3]
C0920316
Signature Principal Investigator
Beschrijving

I certify that the observations and findings are recorded correctly and completely in this CRF.

Datatype

text

Alias
UMLS CUI [1]
C2346576
Date of signature
Beschrijving

I certify that the observations and findings are recorded correctly and completely in this CRF. day/month/year

Datatype

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Terug naar het begin van de pagina

Similar models

Investigator's Check list

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 Group
Investigators checklist
C1707357 (UMLS CUI-1)
C0008961 (UMLS CUI-2)
Check Adverse Event forms
Item
Check all Adverse Event forms are up to date and complete
boolean
C0877248 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Check Concomitant Medication form
Item
Check that the Concomitant Medication form is up to date
boolean
C2347852 (UMLS CUI [1,1])
C0920316 (UMLS CUI [1,2])
C0237400 (UMLS CUI [1,3])
Check signatures
Item
Check that all appropriate pages are signed (thus indicating completion) and dated
boolean
C1283174 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Check laboratory results
Item
Check that laboratory results are included
boolean
C1283174 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
Signature Principal Investigator
Item
Signature Principal Investigator
text
C2346576 (UMLS CUI [1])
Date of signature
Item
Date of signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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