ID

36094

Beschreibung

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 Dosing Details form. It has to be filled in for all sessions each for day 1.

Stichworte

Versionen (1)
  1. 15.04.19 15.04.19 -
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GlaxoSmithKline

Hochgeladen am

15. April 2019

DOI

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Creative Commons BY-NC 3.0
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Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

Englisch

Dosing Details

1 Formulare  
  1. StudyEvent: ODM
    1. Dosing Details
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722 (Administrative documentation)
SNOMED
405624007
Subject No.
Beschreibung

Subject No.

Datentyp

text

Alias
UMLS CUI [1]
C2348585 (Clinical Trial Subject Unique Identifier)
Panel ID
Beschreibung

Panel ID

Datentyp

text

Alias
UMLS CUI [1]
C3846158 (Other Coding)
LOINC
LA4728-7
Visit type
Beschreibung

Visit type

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082 (Visit)
UMLS CUI [1,2]
C0332307 (Type - attribute)
SNOMED
261664005
Visit Date
Beschreibung

day month year

Datentyp

date

Alias
UMLS CUI [1]
C1320303 (Date of visit)
SNOMED
406543005
Dosing Details
Beschreibung

Dosing Details

Alias
UMLS CUI-1
C0013227 (Pharmaceutical Preparations)
SNOMED
763158003
LOINC
LP100609-9
UMLS CUI-2
C0178602 (Dosage)
SNOMED
260911001
LOINC
LP7180-5
Exact time of dosing
Beschreibung

00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0178602 (Dosage)
SNOMED
260911001
LOINC
LP7180-5
UMLS CUI [1,2]
C0040223 (Time)
SNOMED
410670007
LOINC
LP73517-2
Dose checked and administered by
Beschreibung

Dose checked and administered by

Datentyp

text

Alias
UMLS CUI [1,1]
C1283174 (Checking (action))
SNOMED
360160009
LOINC
LP35034-5
UMLS CUI [1,2]
C0178602 (Dosage)
SNOMED
260911001
LOINC
LP7180-5
UMLS CUI [1,3]
C2826892 (Investigator Name)
UMLS CUI [2,1]
C0806914 (Medication administered)
LOINC
MTHU008310
UMLS CUI [2,2]
C2826892 (Investigator Name)
Dose checked and witnessed by
Beschreibung

Dose checked and witnessed by

Datentyp

text

Alias
UMLS CUI [1,1]
C0682356 (Witnesses)
UMLS CUI [1,2]
C1283174 (Checking (action))
SNOMED
360160009
LOINC
LP35034-5
UMLS CUI [1,3]
C0178602 (Dosage)
SNOMED
260911001
LOINC
LP7180-5
Comments
Beschreibung

Comments

Datentyp

text

Alias
UMLS CUI [1]
C0947611 (Comment)
LOINC
LP72293-1
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Ähnliche Modelle

Dosing Details

1 Formulare
  1. StudyEvent: ODM
    1. Dosing Details
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject No.
Item
Subject No.
text
C2348585 (UMLS CUI [1])
Panel ID
Item
Panel ID
text
C3846158 (UMLS CUI [1])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
Session 1 day 1 (1)
CL Item
Session 2 day 1  (2)
CL Item
Session 3 day 1 (3)
CL Item
Session 4 day 1 (4)
CL Item
Session 5 day 1 (5)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Dosing Details
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
Exact time of dosing
Item
Exact time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Dose checked and administered by
Item
Dose checked and administered by
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2826892 (UMLS CUI [1,3])
C0806914 (UMLS CUI [2,1])
C2826892 (UMLS CUI [2,2])
Dose checked and witnessed by
Item
Dose checked and witnessed by
text
C0682356 (UMLS CUI [1,1])
C1283174 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

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