ID
44252
Beschrijving
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
Trefwoorden
Versies (2)
- 14-01-19 14-01-19 -
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 september 2021
DOI
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Licentie
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)
12-Lead Electrocardiogram
- StudyEvent: ODM
Beschrijving
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Beschrijving
The field Row number is not to be filled in for "mean".
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Time relative to dosing. The row numbers denote the time values under "planned relative time". Session 1: Three measurements for screening (at least 5 minutes apart). Session 2, day 1: 3 measurements (at least 5 minutes apart) at pre-dose. The mean value recorded pre-dose will be classed as baseline. Then measurements at 20mins, 40mins, 1hr, 2hrs, 3hrs, 4hrs, 6hrs, 8hrs, 10hrs, 12hrs, 16hrs, 24hrs. Session 2, day 3,5,8,10,12: One measurement for "pre-dose", remaining measurements as at day 1. Session 2, day 7: One measurement at "pre-dose". Session 2, day 14: one measurement at 24hrs. Session 3: One measurement for Follow-up. Measurements at 24hrs are performed immediately prior to dosing on the following day. Planned relative time "unscheduled" can be filled in at each session and each day if neccessary.
Datatype
text
Alias
- UMLS CUI [1]
- C0439564
Beschrijving
Actual time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0430456
Beschrijving
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C2189285
- UMLS CUI [1,2]
- C0430456
Beschrijving
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0429087
- UMLS CUI [1,2]
- C0430456
Beschrijving
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0429025
- UMLS CUI [1,2]
- C0430456
Beschrijving
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C0430456
Beschrijving
ECG measurements will be made with the subject in a supine position having rested in this position for at least 10 minutes before each reading.
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0430456
Beschrijving
ECG normal or abnormal
Datatype
text
Alias
- UMLS CUI [1]
- C0522054
- UMLS CUI [2]
- C0522055
Beschrijving
If abnormalities are present which are clinically significant, complete additional ECG ABNORMALITIES FORM. Copy the session number from the top of this form and the date and time to the ECG ABNORMALITIES FORM.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C2985739
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12-Lead Electrocardiogram
- StudyEvent: ODM
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])