ID
36009
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 Predose Drug Screening/Alcohol Breath Test form. It has to be filled in for all Sessions each on Day 1 and for screening.
Keywords
Versions (1)
- 4/9/19 4/9/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
April 9, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Predose Drug Screening/Alcohol Breath Test
- StudyEvent: ODM
Description
Drug Screening
Alias
- UMLS CUI-1
- C0373483
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0040223
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0040223
Description
If YES, please record all the relevant contra-indicated drugs below.
Data type
text
Alias
- UMLS CUI [1,1]
- C1511790
- UMLS CUI [1,2]
- C1444657
- UMLS CUI [1,3]
- C1254351
Description
Type of drug
Data type
text
Alias
- UMLS CUI [1]
- C0457591
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Alcohol breath test
Alias
- UMLS CUI-1
- C0202306
Similar models
Predose Drug Screening/Alcohol Breath Test
- StudyEvent: ODM
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,2])
C1254351 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
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