ID

36090

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 Laboratory Collections form. It has to be filled in for screening and Follow-up.

Trefwoorden

  1. 15-04-19 15-04-19 -
  2. 15-04-19 15-04-19 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

15 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

Laboratory Collections

  1. StudyEvent: ODM
    1. Laboratory Collections
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Beschrijving

Subject No.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Beschrijving

Panel ID

Datatype

text

Alias
UMLS CUI [1]
C3846158
Visit type
Beschrijving

Visit type

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Visit Date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
CLINICAL CHEMISTRY and HAEMATOLOGY
Beschrijving

CLINICAL CHEMISTRY and HAEMATOLOGY

Alias
UMLS CUI-1
C0008000
UMLS CUI-2
C0018941
Exact time of sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0040223
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschrijving

If YES, please record diagnosis on Baseline Signs and Symptoms page.

Datatype

text

Alias
UMLS CUI [1]
C0438215
URINALYSIS
Beschrijving

URINALYSIS

Alias
UMLS CUI-1
C0042014
Exact time of sampling
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0040223
Comments
Beschrijving

Comments

Datatype

text

Alias
UMLS CUI [1]
C0947611
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
Beschrijving

If YES, please record diagnosis on Baseline Signs and Symptoms page.

Datatype

text

Alias
UMLS CUI [1]
C0438142

Similar models

Laboratory Collections

  1. StudyEvent: ODM
    1. Laboratory Collections
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Code List
Visit type
CL Item
screening (1)
CL Item
follow-up (2)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
CLINICAL CHEMISTRY and HAEMATOLOGY
C0008000 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Time of sampling
Item
Exact time of sampling
time
C0178913 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0438215 (UMLS CUI [1])
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)
Item Group
URINALYSIS
C0042014 (UMLS CUI-1)
Time of sampling
Item
Exact time of sampling
time
C0178913 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Item
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
text
C0438142 (UMLS CUI [1])
Code List
Are there CLINICALLY SIGNIFICANT ABNORMAL values?
CL Item
Yes (Y)
CL Item
No (N)

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