ID
41262
Beschreibung
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)
Stichworte
Versionen (1)
- 03.08.20 03.08.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. August 2020
DOI
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Lizenz
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
Beschreibung
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschreibung
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
Date of subject completion or withdrawal
Datentyp
date
Alias
- UMLS CUI [1]
- C2983670
Beschreibung
Time of withdrawal
Datentyp
time
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0040223
Beschreibung
Was the subject withdrawn from the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschreibung
Primary reason for withdrawal
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beschreibung
If other reason for withdrawal, sepcify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschreibung
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Beschreibung
Investigator's Signature
Alias
- UMLS CUI-1
- C2346576
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Investigator's name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Investigator's signature date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Ähnliche Modelle
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])