ID

36092

Description

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 smoking history for sessions form. It has to be filled in for all sessions for each day 1 and day 2.

Mots-clés

  1. 15/04/2019 15/04/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

15 avril 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

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

Smoking History for sessions

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Type de données

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Type de données

text

Alias
UMLS CUI [1]
C3826248
Visit type
Description

Visit type

Type de données

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Smoking history
Description

Smoking history

Alias
UMLS CUI-1
C1519384
Date
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C0011008
Number of cigarettes
Description

Number of cigarettes

Type de données

integer

Alias
UMLS CUI [1]
C3694146
Comments
Description

Comments

Type de données

text

Alias
UMLS CUI [1]
C0947611

Similar models

Smoking History for sessions

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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
C3826248 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 1 day 2 (2)
CL Item
Session 2 day 1  (3)
CL Item
Session 2 day 2 (4)
CL Item
Session 3 day 1 (5)
CL Item
Session 3 day 2 (6)
CL Item
Session 4 day 1 (7)
CL Item
Session 4 day 2 (8)
CL Item
Session 5 day 1 (9)
CL Item
Session 5 day 2 (10)
Item Group
Smoking history
C1519384 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Number of cigarettes
Item
Number of cigarettes
integer
C3694146 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

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