ID

41691

Descrizione

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.

Keywords

versioni (2)

1. 17/12/20 17/12/20 -
2. 18/12/20 18/12/20 - Sarah Riepenhausen

Titolare del copyright

GlaxoSmithKline

Caricato su

18 dicembre 2020

DOI

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