ID
41732
Beskrivning
The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.
Nyckelord
Versioner (2)
- 2021-01-09 2021-01-09 -
- 2021-01-09 2021-01-09 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
9 januari 2021
DOI
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Licens
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Pharmacogenetic Research
- StudyEvent: ODM
Beskrivning
PGx-Pharmacogenetic Research Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
Beskrivning
informed consent for pharmacogenetic research
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Beskrivning
pharmacogenetic research consent, date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C0011008
Beskrivning
pharmacogenetic research, blood sample
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C2347500
Beskrivning
date blood sample taken, pharmacogenetic test
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2347500
Beskrivning
pharmacogenetic tests, no consent, reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0332197
- UMLS CUI [1,4]
- C0566251
Beskrivning
pharmacogenetic tests, no consent, other reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0332197
- UMLS CUI [1,4]
- C3840932
Beskrivning
genetics type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0017399
- UMLS CUI [1,2]
- C0332307
Beskrivning
PGx-Pharmacogenetic Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Beskrivning
withdrawn consent for PGx-Pharmacogenetic research
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Beskrivning
pharmacogenetic research, request for sample destruction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
Beskrivning
pharmacogenetic research, request for sample destruction, reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C0566251
Beskrivning
pharmacogenetic research, request for sample destruction, other reason
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C3840932
Beskrivning
pharmacogenetic tests, genetics type
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0017399
- UMLS CUI [1,3]
- C0332307
Similar models
Pharmacogenetic Research
- StudyEvent: ODM
C0021430 (UMLS CUI-2)
C2347500 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C2347500 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C2347500 (UMLS CUI [1,3])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C0021430 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
C0332307 (UMLS CUI [1,2])
C0021430 (UMLS CUI-2)
C2349954 (UMLS CUI-3)
C0021430 (UMLS CUI [1,2])
C2349954 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C1948029 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C3840932 (UMLS CUI [1,4])
C0017399 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])