ID
41732
Description
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be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.
Mots-clés
Versions (2)
- 09/01/2021 09/01/2021 -
- 09/01/2021 09/01/2021 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
9 janvier 2021
DOI
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Licence
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Pharmacogenetic Research
- StudyEvent: ODM
Description
PGx-Pharmacogenetic Research Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
Description
informed consent for pharmacogenetic research
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Description
pharmacogenetic research consent, date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C0011008
Description
pharmacogenetic research, blood sample
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C2347500
Description
date blood sample taken, pharmacogenetic test
Type de données
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2347500
Description
pharmacogenetic tests, no consent, reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0332197
- UMLS CUI [1,4]
- C0566251
Description
pharmacogenetic tests, no consent, other reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0332197
- UMLS CUI [1,4]
- C3840932
Description
genetics type
Type de données
text
Alias
- UMLS CUI [1,1]
- C0017399
- UMLS CUI [1,2]
- C0332307
Description
PGx-Pharmacogenetic Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Description
withdrawn consent for PGx-Pharmacogenetic research
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Description
pharmacogenetic research, request for sample destruction
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
Description
pharmacogenetic research, request for sample destruction, reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C0566251
Description
pharmacogenetic research, request for sample destruction, other reason
Type de données
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C3840932
Description
pharmacogenetic tests, genetics type
Type de données
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])