ID
41687
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 at the at the P1 D-1, P2 D-1, P1 D1 and P2 D1 Visits.
Keywords
Versions (1)
- 12/17/20 12/17/20 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 17, 2020
DOI
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License
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Meal
- StudyEvent: ODM
Description
Dosing date and time
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0011008
- UMLS CUI-4
- C0040223
Description
Meal
Alias
- UMLS CUI-1
- C1998602
Description
please fill out all of the meal times at which you have eaten for the P1 D1 and P2 D1 visits. For the P1 D-1 and P2 D-1 Visits, the meal pre-dose is a breakfast, please check the "pre-dose" box.
Data type
text
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0439564
- UMLS CUI [1,3]
- C0178602
Description
meal type
Data type
text
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0332307
Description
meal: date and start time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1998602
- UMLS CUI [2,1]
- C1301880
- UMLS CUI [2,2]
- C1998602
Description
meal: date and stop time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1998602
- UMLS CUI [2,1]
- C1522314
- UMLS CUI [2,2]
- C1998602
Description
totality of meal ingested
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1998602
- UMLS CUI [1,2]
- C0205197
Description
% of meal consumed:
Data type
text
Alias
- UMLS CUI [1]
- C3468056
Similar models
Meal
- StudyEvent: ODM
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
C0439564 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C1998602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C1998602 (UMLS CUI [1,2])
C1522314 (UMLS CUI [2,1])
C1998602 (UMLS CUI [2,2])
C0205197 (UMLS CUI [1,2])