ID
41691
Beskrivning
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 Visits and in case of repeat measurements.
Nyckelord
Versioner (2)
- 2020-12-17 2020-12-17 -
- 2020-12-18 2020-12-18 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
18 december 2020
DOI
För en begäran logga in.
Licens
Creative Commons BY-NC 4.0
Modellkommentarer :
Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.
Itemgroup-kommentar för :
Item-kommentar för :
Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.
GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122
Electronically transferred lab data
- StudyEvent: ODM
Beskrivning
Safety Labs
Alias
- UMLS CUI-1
- C0681902
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0332307
Beskrivning
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.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beskrivning
date and time sample collection
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0200345
Beskrivning
lab test type code
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0805701
Similar models
Electronically transferred 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])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0200345 (UMLS CUI [2,2])
C0805701 (UMLS CUI [1,2])