ID
41690
Beschreibung
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.
Stichworte
Versionen (2)
- 12.12.20 12.12.20 -
- 18.12.20 18.12.20 - Sarah Riepenhausen
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
18. Dezember 2020
DOI
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Lizenz
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
Beschreibung
Dosing date and time
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0011008
- UMLS CUI-4
- C0040223
Beschreibung
Vital Signs Measurement
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0242485
Beschreibung
vital signs: actual date and time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0518766
- UMLS CUI [2,2]
- C0040223
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
Beschreibung
systolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Ähnliche Modelle
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])