ID

26110

Description

Study ID: 101468/219 Clinical Study ID: 101468/219 Study Title:An open label, randomised, five-way crossover single-dose pharmacokinetic study to assess dosage strength equivalence of ropinirole CR in healthy male and female volunteers 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: Requip Study Indication : Parkinson Disease Documentation part: Prior Medication

Keywords

Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Dose strength equivalence of ropinirole CR in healthy adults Prior Medication 101468/219

English

Prior Medication Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 forms  
Prior Medication
Description

Prior Medication

Alias
UMLS CUI-1
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI-2
C2826257 (Prior Medication Usage)
UMLS CUI-3
C0244821 (ropinirole)
SNOMED
108473005
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
Description

If ’YES’, please record the medications below. NB: Any medications Metabolised by CYPIA2 must be kept constant throughout the study.

Data type

boolean

Alias
UMLS CUI [1]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
drug name
Description

Trade Name Preferred

Data type

text

Alias
UMLS CUI [1]
C2360065 (Medication name)
LOINC
MTHU027854
Single Dose/Unit
Description

dose per unit

Data type

integer

Alias
UMLS CUI [1]
C3174092 (Medication dose)
LOINC
LP116765-1
Frequency of this Dose
Description

medication frequency

Data type

text

Alias
UMLS CUI [1]
C3476109 (Medication frequency)
LOINC
LP149758-7
Route
Description

drug application route

Data type

text

Alias
UMLS CUI [1]
C0013153 (Drug Administration Routes)
SNOMED
410675002
LOINC
LP40261-7
Indication
Description

medication indication

Data type

text

Alias
UMLS CUI [1,1]
C3146298 (Indication)
UMLS CUI [1,2]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
Duration
Description

duration of medication

Data type

text

Alias
UMLS CUI [1,1]
C0449238 (Duration (temporal concept))
SNOMED
762636008
LOINC
LP14744-4
UMLS CUI [1,2]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
End Date
Description

end date of medication

Data type

date

Alias
UMLS CUI [1,1]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI [1,2]
C0806020 (End date)
SNOMED
454551000124105
LOINC
MTHU008302
Continuing at end of study?
Description

continuing medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2826666 (Concomitant Medication Ongoing)
UMLS CUI [1,2]
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
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Similar models

Prior Medication Dose strength equivalence of ropinirole CR in healthy adults 101468/219

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Prior Medication
C0013227 (UMLS CUI-1)
C2826257 (UMLS CUI-2)
C0244821 (UMLS CUI-3)
medication
Item
Has the subject taken any medication within 1 week PRIOR to the first dose of study medication?
boolean
C0013227 (UMLS CUI [1])
drug name
Item
drug name
text
C2360065 (UMLS CUI [1])
dose per unit
Item
Single Dose/Unit
integer
C3174092 (UMLS CUI [1])
medication frequency
Item
Frequency of this Dose
text
C3476109 (UMLS CUI [1])
drug application route
Item
Route
text
C0013153 (UMLS CUI [1])
medication indication
Item
Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
duration of medication
Item
Duration
text
C0449238 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
end date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
continuing medication
Item
Continuing at end of study?
boolean
C2826666 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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