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.

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Versions (1)
  1. 17/01/2019 17/01/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

17 janvier 2019

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Creative Commons BY-NC 3.0
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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

Anglais

Pharmacokinetic Blood and Urine Sampling

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Day number
Description

For pharmacokinetic blood sampling, the form has to be filled in once for each day. Fo pharmacokinetic urine sampling, the form has to be filled in at day 1 and day 13.

Type de données

integer

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0439228
Pharmacokinetic blood sampling
Description

Pharmacokinetic blood sampling

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0870078
Row number
Description

Row number

Type de données

integer

Alias
UMLS CUI [1]
C2348184
Date
Description

Date of Blood Sampling

Type de données

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005767
UMLS CUI [1,4]
C0870078
Planned relative time
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.

Type de données

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005767
UMLS CUI [1,4]
C0870078
Actual time
Description

Actual time of Blood Sampling

Type de données

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005767
UMLS CUI [1,4]
C0870078
Sample number
Description

Sample number of Blood Sampling

Type de données

text

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0005767
PK sample taken
Description

In this study, this item should not be filled in at day 1.

Type de données

boolean

Alias
UMLS CUI [1]
C1277698
Pharmacokinetic urine sampling
Description

Pharmacokinetic urine sampling

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
UMLS CUI-3
C0870078
Row number
Description

Row number

Type de données

integer

Alias
UMLS CUI [1]
C2348184
Planned relative time interval
Description

Planned relative time interval of urine sampling

Type de données

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
Start date
Description

Start date of urine sampling

Type de données

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
Actual start time
Description

Actual start time of urine sampling

Type de données

time

Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
Stop date
Description

Stop date of urine sampling

Type de données

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
Actual stop time
Description

Actual stop time of urine sampling

Type de données

time

Alias
UMLS CUI [1,1]
C1522314
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0042036
UMLS CUI [1,4]
C0870078
Sample number
Description

Sample number of urine sampling

Type de données

text

Alias
UMLS CUI [1,1]
C1299222
UMLS CUI [1,2]
C0031328
UMLS CUI [1,3]
C0042036
Total sample volume
Description

Total urine sample volume

Type de données

integer

Unités de mesure
  • ml
Alias
UMLS CUI [1]
C1278293
ml
10ml aliquot taken
Description

10ml aliquot of urine sampling taken

Type de données

boolean

Alias
UMLS CUI [1,1]
C1510844
UMLS CUI [1,2]
C0200354
Was all urine collected for this interval?
Description

If NO, record details on the INVESTIGATOR COMMENT LOG.

Type de données

boolean

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0205197
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Similar models

Pharmacokinetic Blood and Urine Sampling

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Day number
integer
C0750729 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Day number
Code List
Day number
CL Item
1 (1)
CL Item
3 (3)
CL Item
5 (5)
CL Item
8 (8)
CL Item
10 (10)
CL Item
12 (12)
CL Item
7 (7)
CL Item
13 (13)
CL Item
14 (14)
Item Group
Pharmacokinetic blood sampling
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0870078 (UMLS CUI-3)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1])
Date of Blood Sampling
Item
Date
date
C0011008 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Item
Planned relative time
text
C0439564 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Planned relative time
Code List
Planned relative time
CL Item
Pre-dose (Pre-dose)
CL Item
20mins (20mins)
CL Item
40mins (40mins)
CL Item
1hr (1hr)
CL Item
2hrs (2hrs)
CL Item
3hrs (3hrs)
CL Item
4hrs (4hrs)
CL Item
6hrs (6hrs)
CL Item
8hrs (8hrs)
CL Item
10hrs (10hrs)
CL Item
12hrs (12hrs)
CL Item
16hrs (16hrs)
CL Item
24hrs (24hrs)
Actual time of Blood Sampling
Item
Actual time
time
C0040223 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Sample number of Blood Sampling
Item
Sample number
text
C1299222 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
PK sample taken
Item
PK sample taken
boolean
C1277698 (UMLS CUI [1])
Item Group
Pharmacokinetic urine sampling
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0870078 (UMLS CUI-3)
Row number
Item
Row number
integer
C2348184 (UMLS CUI [1])
Item
Planned relative time interval
text
C0439564 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Planned relative time
Code List
Planned relative time interval
CL Item
0-2hrs (0-2hrs)
CL Item
2-8hrs (2-8hrs)
CL Item
8-24hrs (8-24hrs)
Start date of urine sampling
Item
Start date
date
C0808070 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Actual start time of urine sampling
Item
Actual start time
time
C1301880 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Stop date of urine sampling
Item
Stop date
date
C0806020 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Actual stop time of urine sampling
Item
Actual stop time
time
C1522314 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,4])
Sample number of urine sampling
Item
Sample number
text
C1299222 (UMLS CUI [1,1])
C0031328 (UMLS CUI [1,2])
C0042036 (UMLS CUI [1,3])
Total urine sample volume
Item
Total sample volume
integer
C1278293 (UMLS CUI [1])
10ml aliquot of urine sampling taken
Item
10ml aliquot taken
boolean
C1510844 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Was all urine collected for this interval?
Item
Was all urine collected for this interval?
boolean
C0200354 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
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