ID
34378
Beschreibung
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.
Stichworte
Versionen (1)
- 17.01.19 17.01.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
17. Januar 2019
DOI
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Lizenz
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)
Pharmacokinetic Blood and Urine Sampling
- StudyEvent: ODM
Beschreibung
Pharmacokinetic blood sampling
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
- UMLS CUI-3
- C0870078
Beschreibung
Row number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Date of Blood Sampling
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
- UMLS CUI [1,4]
- C0870078
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
- UMLS CUI [1,4]
- C0870078
Beschreibung
Actual time of Blood Sampling
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
- UMLS CUI [1,4]
- C0870078
Beschreibung
Sample number of Blood Sampling
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
Beschreibung
In this study, this item should not be filled in at day 1.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1277698
Beschreibung
Pharmacokinetic urine sampling
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0042036
- UMLS CUI-3
- C0870078
Beschreibung
Row number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Planned relative time interval of urine sampling
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Beschreibung
Start date of urine sampling
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Beschreibung
Actual start time of urine sampling
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Beschreibung
Stop date of urine sampling
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Beschreibung
Actual stop time of urine sampling
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
- UMLS CUI [1,4]
- C0870078
Beschreibung
Sample number of urine sampling
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0042036
Beschreibung
Total urine sample volume
Datentyp
integer
Maßeinheiten
- ml
Alias
- UMLS CUI [1]
- C1278293
Beschreibung
10ml aliquot of urine sampling taken
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1510844
- UMLS CUI [1,2]
- C0200354
Beschreibung
If NO, record details on the INVESTIGATOR COMMENT LOG.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C0205197
Ähnliche Modelle
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])