ID
41262
Beskrivning
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)
Nyckelord
Versioner (1)
- 2020-08-03 2020-08-03 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
3 augusti 2020
DOI
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Licens
Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature
Beskrivning
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beskrivning
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beskrivning
Date of subject completion or withdrawal
Datatyp
date
Alias
- UMLS CUI [1]
- C2983670
Beskrivning
Time of withdrawal
Datatyp
time
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0040223
Beskrivning
Was the subject withdrawn from the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beskrivning
Primary reason for withdrawal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beskrivning
If other reason for withdrawal, sepcify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beskrivning
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Beskrivning
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beskrivning
I confirm that i have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete, accurate, as of the date below.
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Investigator's name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigator's signature date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature
C0040223 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0947611 (UMLS CUI-2)
C1516308 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])