ID
44252
Descripción
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
Palabras clave
Versiones (2)
- 14/1/19 14/1/19 -
- 20/9/21 20/9/21 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de septiembre de 2021
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 3.0
Comentarios del modelo :
Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.
Comentarios de grupo de elementos para :
Comentarios del elemento para :
Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.
Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)
12-Lead Electrocardiogram
- StudyEvent: ODM
Descripción
12-Lead Electrocardiogram
Alias
- UMLS CUI-1
- C0430456
Descripción
The field Row number is not to be filled in for "mean".
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2348184
Descripción
Date
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0439564
Descripción
Actual time
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0430456
Descripción
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.
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1,1]
- C2189285
- UMLS CUI [1,2]
- C0430456
Descripción
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.
Tipo de datos
integer
Unidades de medida
- msec
Alias
- UMLS CUI [1,1]
- C0429087
- UMLS CUI [1,2]
- C0430456
Descripción
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.
Tipo de datos
integer
Unidades de medida
- msec
Alias
- UMLS CUI [1,1]
- C0429025
- UMLS CUI [1,2]
- C0430456
Descripción
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.
Tipo de datos
integer
Unidades de medida
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C0430456
Descripción
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.
Tipo de datos
integer
Unidades de medida
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0430456
Descripción
ECG normal or abnormal
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0522054
- UMLS CUI [2]
- C0522055
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C2985739
Similar models
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])