ID
38074
Beskrivning
Two-Part Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Oral Dosesof the Enteric-Coated Free Base Formulation of Darapladib (SB-480848) ina Dose Rising Fashion and to Evaluate the Safety, Tolerability and Pharmacokinetics of Darapladib when Co-administered with Ketoconazole in Healthy Adult Subjects. There are 4 parts to this study: Screening, Part A, Part B, and Follow-Up. Part A contains 2 Sessions per day for day 1-10, Part B contains 1 Session per day for day 1-14. Each itemgroup contains information when it should be filled out. The itemgroups of the non-serious and serious adverse event forms contain additional information on the definition of a serious/non-serious adverse event.
Nyckelord
Versioner (1)
- 2019-09-15 2019-09-15 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
15 september 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Darapladib Evaluation Case Report Form GSK LPL107988
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