ID
41690
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 P1 D-1, P1 D1, P2 D-1 and P2 D1 Visits and possible Repeat Measurements . Slight variations are remarked under the concerning items.
Keywords
Versions (2)
- 12/12/20 12/12/20 -
- 12/18/20 12/18/20 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
December 18, 2020
DOI
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License
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Vital Signs, P1 D-1, P1 D1, P2 D-1, P2 D1 and Repeats
- 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
Vital Signs Measurement
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0242485
Description
vital signs: actual date and time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0518766
- UMLS CUI [2,2]
- C0040223
Description
for the Repeats Visit, the following measurements have to be executed and filled out once. for the P1, D-1 and P2 D-1 visit, the following measurements have to be executed and filled out three times. for the P1 D1 and P2 D1 visit, the following measurements have to be executed and filled out three times pre-dose, three times 4 hours after the administration of the dosis, three times 8 hours after the administration of the dosis and three times 12 hours after the administration of the dosis.
Data type
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
Description
systolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
diastolic blood pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Similar models
Vital Signs, P1 D-1, P1 D1, P2 D-1, P2 D1 and Repeats
- StudyEvent: ODM
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0242485 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0518766 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C3469597 (UMLS CUI [1,2])