ID
41732
Beschrijving
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be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.
Trefwoorden
Versies (2)
- 09-01-21 09-01-21 -
- 09-01-21 09-01-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 januari 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Pharmacogenetic Research
- StudyEvent: ODM
Beschrijving
PGx-Pharmacogenetic Research Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
Beschrijving
informed consent for pharmacogenetic research
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
Beschrijving
pharmacogenetic research consent, date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347500
- UMLS CUI [1,3]
- C0011008
Beschrijving
pharmacogenetic research, blood sample
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C2347500
Beschrijving
date blood sample taken, pharmacogenetic test
Datatype
date
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2347500
Beschrijving
pharmacogenetic tests, no consent, reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0332197
- UMLS CUI [1,4]
- C0566251
Beschrijving
pharmacogenetic tests, no consent, other reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C0332197
- UMLS CUI [1,4]
- C3840932
Beschrijving
genetics type
Datatype
text
Alias
- UMLS CUI [1,1]
- C0017399
- UMLS CUI [1,2]
- C0332307
Beschrijving
PGx-Pharmacogenetic Research Withdrawal of Consent
Alias
- UMLS CUI-1
- C2347500
- UMLS CUI-2
- C0021430
- UMLS CUI-3
- C2349954
Beschrijving
withdrawn consent for PGx-Pharmacogenetic research
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C0021430
- UMLS CUI [1,3]
- C2349954
Beschrijving
pharmacogenetic research, request for sample destruction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
Beschrijving
pharmacogenetic research, request for sample destruction, reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C0566251
Beschrijving
pharmacogenetic research, request for sample destruction, other reason
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347500
- UMLS CUI [1,2]
- C1948029
- UMLS CUI [1,3]
- C1272683
- UMLS CUI [1,4]
- C3840932
Beschrijving
pharmacogenetic tests, genetics type
Datatype
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])