ID
25997
Beschrijving
PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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
Trefwoorden
Versies (1)
- 03-10-17 03-10-17 -
Houder van rechten
glaxoSmithKline
Geüploaded op
3 oktober 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
Beschrijving
Concomitant medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
If 'Yes', please document on the Concomitant Medication Report Forms.
Datatype
integer
Alias
- UMLS CUI [1]
- C0580105
Beschrijving
tobacco use unchanged
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0543414
- UMLS CUI [1,2]
- C0442739
Beschrijving
dietary restrictions
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0425422
- UMLS CUI [1,2]
- C1321605
Beschrijving
alcohol consumption restricted
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0001948
- UMLS CUI [1,2]
- C0443288
Beschrijving
Adverse event
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Patient diary
Alias
- UMLS CUI-1
- C3890583
Beschrijving
Patient diary
Datatype
text
Alias
- UMLS CUI [1]
- C3890583
Beschrijving
Standard Breakfast
Alias
- UMLS CUI-1
- C2698559
Beschrijving
Breakfast started
Datatype
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0439659
Beschrijving
Breakfast ended
Datatype
time
Alias
- UMLS CUI [1,1]
- C2698559
- UMLS CUI [1,2]
- C0444930
Beschrijving
Breakfast completed
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0814440
- UMLS CUI [1,2]
- C0205197
Beschrijving
Breakfast not completed comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0814440
- UMLS CUI [1,3]
- C0205197
Beschrijving
Pharmacokinetics
Alias
- UMLS CUI-1
- C0031327
Beschrijving
Study Drug Dosing
Alias
- UMLS CUI-1
- C0013175
- UMLS CUI-2
- C0678766
Beschrijving
The subject will not be allowed to lie down or sleep for 4 hours after the morning dose. For subjects receiving IR please document time of administration of 2 further doses on PK Sampling Day.
Datatype
float
Maateenheden
- mg/day
Alias
- UMLS CUI [1]
- C0678766
Beschrijving
Dosage
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C3854006
Beschrijving
Time of Dosing
Datatype
time
Maateenheden
- 24hr:min
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beschrijving
Study medication dispensed
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3854006
- UMLS CUI [1,2]
- C0947323
Beschrijving
Witness 1
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschrijving
Witness date 1
Datatype
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschrijving
Witness 2
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschrijving
Witness date 2
Datatype
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschrijving
Study Drug Dosing - Lunch
Alias
- UMLS CUI-1
- C0013175
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C2697949
Beschrijving
Lunch start
Datatype
time
Alias
- UMLS CUI [1,1]
- C2697949
- UMLS CUI [1,2]
- C0439659
Beschrijving
Lunch end
Datatype
time
Alias
- UMLS CUI [1,1]
- C2697949
- UMLS CUI [1,2]
- C0444930
Beschrijving
8 hours after first dose - date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0439568
Beschrijving
8 hours after first dose - time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0439568
Beschrijving
Witness 1
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschrijving
Witness date 1
Datatype
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschrijving
Witness 2
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschrijving
Witness date 2
Datatype
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschrijving
Study Drug Dosing - Dinner
Alias
- UMLS CUI-1
- C0013175
- UMLS CUI-2
- C0678766
- UMLS CUI-3
- C4048877
Beschrijving
Dinner start
Datatype
time
Alias
- UMLS CUI [1,1]
- C4048877
- UMLS CUI [1,2]
- C0439659
Beschrijving
Dinner end
Datatype
time
Alias
- UMLS CUI [1,1]
- C4048877
- UMLS CUI [1,2]
- C0444930
Beschrijving
16 hours after first dose - date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0439568
Beschrijving
16 hours after first dose - time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0439568
Beschrijving
Witness 1
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschrijving
Witness date 1
Datatype
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschrijving
Witness 2
Datatype
text
Alias
- UMLS CUI [1,1]
- C0682356
- UMLS CUI [1,2]
- C0001555
Beschrijving
Witness date 2
Datatype
date
Alias
- UMLS CUI [1,1]
- C4263486
- UMLS CUI [1,2]
- C0011008
Beschrijving
Pharmacokinetic sampling post dosing (CR)
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0370003
Beschrijving
Sample ID and specified time
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C1444698
Beschrijving
Actual time sample
Datatype
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0040223
Beschrijving
Date sample
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Pharmacokinetic sampling post dosing (IR)
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0370003
Beschrijving
Sample ID and specified time
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C1444698
Beschrijving
Actual time sample
Datatype
time
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C0040223
Beschrijving
Date sample
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Similar models
PART A - Period 2 - Day 4 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
C3812758 (UMLS CUI-4)
C3812758 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
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C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
C3812758 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,2])
C0439659 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0807979 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0947323 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0678766 (UMLS CUI-2)
C2697949 (UMLS CUI-3)
C0439659 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0678766 (UMLS CUI-2)
C4048877 (UMLS CUI-3)
C0439659 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0001555 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0370003 (UMLS CUI-2)
C1444698 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0370003 (UMLS CUI-2)
C1444698 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
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