ID
41686
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 Screening, the P1 D-1, P1 D1, P2 D-1, P2 D1, the Follow-Up and possible Repeat Visits.
Mots-clés
Versions (2)
- 17/12/2020 17/12/2020 -
- 18/12/2020 18/12/2020 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
17 décembre 2020
DOI
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Licence
Creative Commons BY-NC 4.0
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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Electronically transformed lab data
- StudyEvent: ODM
Description
Safety Labs
Alias
- UMLS CUI-1
- C0681902
Description
for most of the visits defined in the study description, all of the tests are necessary. for possible repeating visits, only the repeated tests have to be filled out.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0332307
Description
if clinical chemistry is taken at the same time as hematology, please choose the option "same as previous sample". The option "same as previous sample" cannot be chosen for possible repeating visits. Please specify the date of the sampling.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Description
date and time
Type de données
datetime
Alias
- UMLS CUI [1]
- C0011008
- UMLS CUI [2]
- C0040223
Description
lab test type code
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Similar models
Electronically transformed lab data
- StudyEvent: ODM
C0200345 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2])
C0805701 (UMLS CUI [1,2])