ID
36011
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. This document contains the Alcohol Consumption and Smoking History form. It has to be filled in for screening.
Trefwoorden
Versies (5)
- 29-08-17 29-08-17 -
- 05-09-17 05-09-17 -
- 06-09-17 06-09-17 -
- 05-10-17 05-10-17 -
- 09-04-19 09-04-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 april 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198
Alcohol Consumption, Smoking History
- StudyEvent: ODM
Beschrijving
Alcohol Consumption
Alias
- UMLS CUI-1
- C0001948
Beschrijving
1 unit is equivalent to half a pint of beer (ca. 0,57 l), one measure of spirits or one glass of wine.
Datatype
integer
Alias
- UMLS CUI [1]
- C0560578
Beschrijving
1 unit is equivalent to half a pint of beer (ca. 0,57 l), one measure of spirits or one glass of wine.
Datatype
integer
Alias
- UMLS CUI [1]
- C0560579
Beschrijving
Smoking History
Alias
- UMLS CUI-1
- C1519384
Beschrijving
Smoking history details
Alias
- UMLS CUI-1
- C0543414
- UMLS CUI-2
- C1522508
Beschrijving
Smoking years
Datatype
integer
Maateenheden
- years
Alias
- UMLS CUI [1,1]
- C0037369
- UMLS CUI [1,2]
- C0439234
- UMLS CUI [1,3]
- C0449788
Beschrijving
Cigarettes per day
Datatype
integer
Alias
- UMLS CUI [1]
- C3694146
Beschrijving
(eg. pipe, chigar, chewing tobacco or cigarette)
Datatype
text
Alias
- UMLS CUI [1]
- C3166496
Similar models
Alcohol Consumption, Smoking History
- StudyEvent: ODM
C1522508 (UMLS CUI-2)
C0439234 (UMLS CUI [1,2])
C0449788 (UMLS CUI [1,3])
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