ID

36094

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 Dosing Details form. It has to be filled in for all sessions each for day 1.

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

Dosing Details

  1. StudyEvent: ODM
    1. Dosing Details
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]
C3846158
Visit type
Description

Visit type

Type de données

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Description

day month year

Type de données

date

Alias
UMLS CUI [1]
C1320303
Dosing Details
Description

Dosing Details

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
Exact time of dosing
Description

00:00-23:59

Type de données

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Dose checked and administered by
Description

Dose checked and administered by

Type de données

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2826892
UMLS CUI [2,1]
C0806914
UMLS CUI [2,2]
C2826892
Dose checked and witnessed by
Description

Dose checked and witnessed by

Type de données

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C1283174
UMLS CUI [1,3]
C0178602
Comments
Description

Comments

Type de données

text

Alias
UMLS CUI [1]
C0947611

Similar models

Dosing Details

  1. StudyEvent: ODM
    1. Dosing Details
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
C3846158 (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 2 day 1  (2)
CL Item
Session 3 day 1 (3)
CL Item
Session 4 day 1 (4)
CL Item
Session 5 day 1 (5)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Exact time of dosing
Item
Exact time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dose checked and administered by
Item
Dose checked and administered by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2826892 (UMLS CUI [1,3])
C0806914 (UMLS CUI [2,1])
C2826892 (UMLS CUI [2,2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C0682356 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
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