4 results
Supported by the observation from the Phase I studies in healthy volunteers, doses within a range of 50 to 500 mg are safe and well tolerated. This Phase II trial will be performed to:a. obtain proof of concept of BI 44370 TAb. perform dose finding…
OBJECTIVES AND HYPOTHESISPrimary ObjectivesThe primary objectives are to determine- the effect of steady-state telaprevir 750 mg every 8 hours (q8h) on the multiple dose pharmacokinetics ofphenytoin 200 mg every 12 hours (q12h) in healthy subjects,…
To evaluate in detail the functionality of immune cells in the liver and blood in chronic HCV patients before, during and after treatment with telaprevir, pegylated-IFN-alfa and ribavirin.
Primary objective:To show that concomitant use of telaprevir (1125 mg BID) does not lead to a relevant decrease (> 20%) in the paroxetine parameter AUC0-24h compared to paroxetine alone.Secondary objectives:To determine the ratio of the…