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GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Slit lamp, Biomicrosopy, Visual acuity and indirect ophthalmoscopy

- 12/12/2020 - 1 Formulär, 5 Item-grupper, 26 Dataelement, 1 Språk

Item-grupper: Administrative Data, slit lamp examination, slit lamp biomicroscopy, visual acuity, Indirect Ophtalmoscopy

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 and Follow-Up Visits.

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