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

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License

Creative Commons BY-NC 3.0
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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
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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])
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