ID
41262
Description
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)
Keywords
Versions (1)
- 8/3/20 8/3/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
August 3, 2020
DOI
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License
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
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
Date of subject completion or withdrawal
Data type
date
Alias
- UMLS CUI [1]
- C2983670
Description
Time of withdrawal
Data type
time
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0040223
Description
Was the subject withdrawn from the study?
Data type
boolean
Alias
- UMLS CUI [1]
- C0422727
Description
Primary reason for withdrawal
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Description
If other reason for withdrawal, sepcify
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Description
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Description
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Description
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.
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator's signature date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Pregnancy Information; Study Conclusion; Investigator Comment Log; Investigator's Signature
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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])