ID

36906

Description

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Pharmacokinetic sampling form. It has to befilled in for Day 1, Day 6, Day 12 and Day 19.

Keywords

Versions (2)
  1. 9/2/17 9/2/17 -
  2. 6/21/19 6/21/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 21, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

English

PK Sampling

1 forms  
  1. StudyEvent: ODM
    1. PK Sampling
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study Week
Description

Study Week

Data type

integer

Alias
UMLS CUI [1,1]
C0008972
UMLS CUI [1,2]
C0439230
Study Day
Description

Study Day

Data type

integer

Alias
UMLS CUI [1]
C2826182
PK SAMPLING
Description

PK SAMPLING

Alias
UMLS CUI-1
C0022877
Time relative to start of dose
Description

Time relative to start of dose

Data type

integer

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301880
UMLS CUI [1,3]
C0178602
Date
Description

day month year The date has to be filled in for Pre-dose, +8 hrs and +10 hrs. If required you can also fill in the date for the other times.

Data type

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0178602
Actual time
Description

00:00-23:59

Data type

time

Alias
UMLS CUI [1]
C0040223
Sample taken
Description

Sample taken

Data type

text

Alias
UMLS CUI [1]
C0200345
Comments
Description

Comments

Data type

text

Alias
UMLS CUI [1]
C0947611
Back to the top of the page

Similar models

PK Sampling

1 forms
  1. StudyEvent: ODM
    1. PK Sampling
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study Week
integer
C0008972 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
Study Week
Code List
Study Week
CL Item
Week 1 (1)
CL Item
Week 2 (2)
CL Item
Week 3 (3)
Item
Study Day
integer
C2826182 (UMLS CUI [1])
Study Day
Code List
Study Day
CL Item
Day 1 (1)
CL Item
Day 6 (2)
CL Item
Day 12 (3)
CL Item
Day 19 (4)
Item Group
PK SAMPLING
C0022877 (UMLS CUI-1)
Item
Time relative to start of dose
integer
C0439564 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Time relative to start of dose
Code List
Time relative to start of dose
CL Item
Pre-dose (1)
CL Item
+0,25 hr (2)
CL Item
+0,5 hr (3)
CL Item
+0,75 hr (4)
CL Item
+1 hr (5)
CL Item
+2 hrs (6)
CL Item
+3 hrs (7)
CL Item
+4 hrs (8)
CL Item
+6 hrs (9)
CL Item
+8 hrs (10)
CL Item
+10 hrs (11)
CL Item
+12 hrs (12)
CL Item
+14 hrs (13)
CL Item
+16 hrs (14)
CL Item
+24 hrs (15)
Date of start dose
Item
Date
date
C0808070 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Item
Sample taken
text
C0200345 (UMLS CUI [1])
Sample taken
Code List
Sample taken
CL Item
Yes (Y)
CL Item
No (N)
Comments
Item
Comments
text
C0947611 (UMLS CUI [1])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial