ID
36028
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 Pregnancy Information and Study Conclusion form. It has to be filled in for follow-up.
Mots-clés
Versions (1)
- 09/04/2019 09/04/2019 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
9 avril 2019
DOI
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Licence
Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Pregnancy Information, Study Conclusion
- StudyEvent: ODM
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
(mark one box below) If 'Yes' record details on Pregnancy Notification Form.
Type de données
text
Alias
- UMLS CUI [1]
- C3828490
Description
(mark one box below) If 'Yes' record details on Pregnancy Notification Form.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0919624
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008972
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Subject completed study
Type de données
text
Alias
- UMLS CUI [1,1]
- C2983670
- UMLS CUI [1,2]
- C2986196
Description
IF you tick AE, please complete AE form.
Type de données
integer
Alias
- UMLS CUI [1]
- C3827242
Description
Other reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C1521902
Description
Comments
Type de données
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C2349954
- UMLS CUI [1,3]
- C0566251
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0011008
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0040223
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C1762893
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1]
- C0946444
Similar models
Pregnancy Information, Study Conclusion
- StudyEvent: ODM
C0347984 (UMLS CUI [1,2])
C0008972 (UMLS CUI [1,3])
C2986196 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])