ID
41681
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 Visit, the P1 D1 and P2 D1, the Follow-Up Visit and whenever a repeat ECG measurement was conducted during the study.
Mots-clés
Versions (1)
- 12/12/2020 12/12/2020 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
12 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
12-Lead ECG
- 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
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
this item only needs to be filled out for the Screening Visit , Follow-Up Visit and possible Repeat Visits.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0011008
Description
this item only has to be filled out for the P1 D1 and P2 D1 visit
Type de données
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0178602
Description
time of ECG
Type de données
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Description
ECG: heart rate
Type de données
integer
Unités de mesure
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Description
ECG: PR interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429087
Description
ECG: QRS duration
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0429025
Description
ECG: uncorrected QT-interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1287082
Description
ECG: QTc interval
Type de données
integer
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0855331
Description
result of the ECG
Type de données
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1274040
Similar models
12-Lead ECG
- 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])
C0011008 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])