ID
34378
Description
Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive This form contains information about pharmacokinetic blood and urine sampling. It has to be filled in in Session 2.
Keywords
Versions (1)
- 1/17/19 1/17/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
January 17, 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.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)
Pharmacokinetic Blood and Urine Sampling
- StudyEvent: ODM
Description
Pharmacokinetic blood sampling
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0870078
Description
Row number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Date of Blood Sampling
Data type
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
- UMLS CUI [1,4]
- C0870078
Description
Day 1: each one measurement at Pre-dose, 15mins, 30mins, 40mins, 1hr, 2hrs, 3hrs, 4hrs, 8hrs, 12hrs, 24hrs. Day 3, 5, 8, 10: each one measurement at Pre-dose, 24hrs. Day 7, 12: one measurement at Pre-Dose. Day 13: each one measurement at Pre-dose, 15mins, 30mins, 40mins, 1hr, 2hrs, 3hrs, 4hrs, 8hrs, 12hrs. Day 14: one measurement at 24hrs. 8hrs: 15mcg and 25mcg dose groups only. 12hrs: 25mcg dose group only. 24hrs: To be performed immediately prior to dosing on the following day.
Data type
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
- UMLS CUI [1,4]
- C0870078
Description
Actual time of Blood Sampling
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
- UMLS CUI [1,4]
- C0870078
Description
Sample number of Blood Sampling
Data type
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
Description
In this study, this item should not be filled in at day 1.
Data type
boolean
Alias
- UMLS CUI [1]
- C1277698
Description
Pharmacokinetic urine sampling
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0042036
- UMLS CUI-3
- C0870078
Description
Row number
Data type
integer
Alias
- UMLS CUI [1]
- C2348184
Description
Planned relative time interval of urine sampling
Data type
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Description
Start date of urine sampling
Data type
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Description
Actual start time of urine sampling
Data type
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Description
Stop date of urine sampling
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Description
Actual stop time of urine sampling
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Description
Sample number of urine sampling
Data type
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
Description
Total urine sample volume
Data type
integer
Measurement units
- ml
Alias
- UMLS CUI [1]
- C1278293
Description
10ml aliquot of urine sampling taken
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1510844
- UMLS CUI [1,2]
- C0200354
Description
If NO, record details on the INVESTIGATOR COMMENT LOG.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0205197
Similar models
Pharmacokinetic Blood and Urine Sampling
- StudyEvent: ODM
C0005767 (UMLS CUI-2)
C0870078 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0042036 (UMLS CUI-2)
C0870078 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0200354 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])