ID

44521

Description

Study part: Pharmacokinetics. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

Mots-clés

  1. 17/06/2018 17/06/2018 -
  2. 27/09/2021 27/09/2021 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

27 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

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Pharmacokinetics Pazopanib Macular Degeneration MD1103367

Pharmacokinetics

  1. StudyEvent: ODM
    1. Pharmacokinetics
PHARMACOKINETICS BLOOD - GW786034 (PK)
Description

PHARMACOKINETICS BLOOD - GW786034 (PK)

Alias
UMLS CUI-1
C0031327
UMLS CUI-2
C0005767
Study part
Description

Study part

Type de données

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
Interval
Description

Time interval

Type de données

text

Alias
UMLS CUI [1]
C0872291
Dosing date/time
Description

date and time dosage

Type de données

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0178602
Actual time
Description

Time

Type de données

time

Alias
UMLS CUI [1]
C0040223
Sample ID
Description

Sample ID

Type de données

text

Alias
UMLS CUI [1]
C1299222
PHARMACOKINETICS URINE GW786034 (PKU)
Description

PHARMACOKINETICS URINE GW786034 (PKU)

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0042036
Study part
Description

Study part

Type de données

text

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0449719
Interval
Description

Time interval

Type de données

text

Alias
UMLS CUI [1]
C0872291
Dosing date/time
Description

date and time dosage

Type de données

datetime

Alias
UMLS CUI [1,1]
C1264639
UMLS CUI [1,2]
C0178602
Was all of the sample collected for this interval?
Description

sample collection

Type de données

text

Alias
UMLS CUI [1]
C0200345
Start date and Actual start time
Description

Start date and time

Type de données

datetime

Alias
UMLS CUI [1]
C3897500
Stop date and Actual stop time
Description

Stop date and time

Type de données

datetime

Alias
UMLS CUI [1]
C3899266
Total sample volume
Description

sample volume

Type de données

float

Unités de mesure
  • ml
Alias
UMLS CUI [1,1]
C0370003
UMLS CUI [1,2]
C0449468
ml
Sample pH
Description

Sample pH

Type de données

float

Alias
UMLS CUI [1]
C0042044
Sample ID
Description

Sample ID

Type de données

text

Alias
UMLS CUI [1]
C1299222

Similar models

Pharmacokinetics

  1. StudyEvent: ODM
    1. Pharmacokinetics
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
PHARMACOKINETICS BLOOD - GW786034 (PK)
C0031327 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Code List
Study part
CL Item
Day 1 (Day 1)
CL Item
Day 14 (Day 14)
Item
Interval
text
C0872291 (UMLS CUI [1])
Code List
Interval
CL Item
Predose (Predose)
CL Item
0.5 Hours (0.5 Hours)
CL Item
1 Hour (1 Hour)
CL Item
2 Hours (2 Hours)
CL Item
3 Hours (3 Hours)
CL Item
4 Hours (4 Hours)
CL Item
6 Hours (6 Hours)
CL Item
8 Hours (8 Hours)
CL Item
12 Hours (12 Hours)
CL Item
24 Hours (24 Hours)
date and time dosage
Item
Dosing date/time
datetime
C1264639 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Sample ID
Item
Sample ID
text
C1299222 (UMLS CUI [1])
Item Group
PHARMACOKINETICS URINE GW786034 (PKU)
C0031328 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
Item
Study part
text
C0008976 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
Code List
Study part
CL Item
Day 1 (Day 1)
CL Item
Day 14 (Day 14)
Item
Interval
text
C0872291 (UMLS CUI [1])
Code List
Interval
CL Item
-2- 0 Hours (-2- 0 Hours)
CL Item
0 - 4 Hours (0 - 4 Hours)
CL Item
4 - 8 Hours (4 - 8 Hours)
CL Item
8 - 12 Hours (8 - 12 Hours)
CL Item
12 - 24 Hours (12 - 24 Hours)
date and time dosage
Item
Dosing date/time
datetime
C1264639 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
Item
Was all of the sample collected for this interval?
text
C0200345 (UMLS CUI [1])
Code List
Was all of the sample collected for this interval?
CL Item
Yes (Y)
CL Item
No (N)
Start date and time
Item
Start date and Actual start time
datetime
C3897500 (UMLS CUI [1])
Stop date and time
Item
Stop date and Actual stop time
datetime
C3899266 (UMLS CUI [1])
sample volume
Item
Total sample volume
float
C0370003 (UMLS CUI [1,1])
C0449468 (UMLS CUI [1,2])
Sample pH
Item
Sample pH
float
C0042044 (UMLS CUI [1])
Sample ID
Item
Sample ID
text
C1299222 (UMLS CUI [1])

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