ID

36010

Description

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 Plasma Drug Assay fomr. It has to be filled in for all Sessions each for both Day 1 and Day 2.

Keywords

Versions (1)
  1. 4/9/19 4/9/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 9, 2019

DOI

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License

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

English

Plasma Drug Assay

1 forms  
  1. StudyEvent: ODM
    1. Plasma Drug Assay
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject No.
Description

Subject No.

Data type

text

Alias
UMLS CUI [1]
C2348585
Panel ID
Description

Panel ID

Data type

text

Alias
UMLS CUI [1]
C3846158
Visit type
Description

Visit type

Data type

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Plasma Drug Assay
Description

Plasma Drug Assay

Alias
UMLS CUI-1
C1609077
UMLS CUI-2
C1261153
Date of dosing
Description

day month year

Data type

date

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
Time of dosing
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Time relative to start of dose, Day 1
Description

Only tick for Day 1.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0178602
Time relative to start of dose, Day 2
Description

Only tick for Day 2.

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0178602
If different from visit date, please note Date of sample
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C1302413
Actual time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0040223
Blood samples taken for Plasma Assay?
Description

Blood samples taken

Data type

text

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C1609077
Initials
Description

Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
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Similar models

Plasma Drug Assay

1 forms
  1. StudyEvent: ODM
    1. Plasma Drug Assay
Name
Type
Description | Question | Decode (Coded Value)
Data type
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 1 day 2 (2)
CL Item
Session 2 day 1  (3)
CL Item
Session 2 day 2 (4)
CL Item
Session 3 day 1 (5)
CL Item
Session 3 day 2 (6)
CL Item
Session 4 day 1 (7)
CL Item
Session 4 day 2 (8)
CL Item
Session 5 day 1 (9)
CL Item
Session 5 day 2 (10)
Item Group
Plasma Drug Assay
C1609077 (UMLS CUI-1)
C1261153 (UMLS CUI-2)
Date of dosing
Item
Date of dosing
date
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of dosing
Item
Time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Time relative to start of dose, Day 1
integer
C0439564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Relative time, Day 1
Code List
Time relative to start of dose, Day 1
CL Item
+15 min (1)
CL Item
+30 min (2)
CL Item
+45 min (3)
CL Item
+1 h (4)
CL Item
+2 h (5)
CL Item
+3 h (6)
CL Item
+4 h (7)
CL Item
+6 h (8)
Item
Time relative to start of dose, Day 2
integer
C0439564 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Relative time, Day 1
Code List
Time relative to start of dose, Day 2
CL Item
+8 j (1)
CL Item
+10 h (2)
CL Item
+12 h (3)
CL Item
+14 h (4)
CL Item
+16 h (5)
CL Item
+24 h (6)
Sample Date
Item
If different from visit date, please note Date of sample
date
C1302413 (UMLS CUI [1])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Item
Blood samples taken for Plasma Assay?
text
C1277698 (UMLS CUI [1,1])
C1609077 (UMLS CUI [1,2])
Blood samples taken
Code List
Blood samples taken for Plasma Assay?
CL Item
Yes (Y)
CL Item
No (N)
Initials
Item
Initials
text
C2986440 (UMLS CUI [1])
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
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