6 results
• To estimate the difference in the efficacy and safety of RAD001 10 mg p.o. daily dose in combination with bevacizumab 10 mg/kg administered intravenously every two weeks for first-line treatment of patients with metastatic carcinoma of the kidney…
The primary objective is to quantify the LIN AUC0-12h increase after addition of 250 mg, or 500 mg CLA compared to baseline (0 mg CLA). The secondary objectives are to describe the LIN and CLA pharmacokinetic parameters and to assess short-term…
To study the pharmacokinetics of linezolid in MDR-TB patients, specifically in the relationship to dose, treatment duration and toxicity.
The Primary Objectives for the study are:* Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent to Treat (ITT) Analysis Set (…
Primary Objective•*To evaluate the relative oral bioavailability of SMV, ODV, and AL-335 when administered as different concept fixed-dose combination (FDC) formulations compared to the single agents when administered together, all under fed…
The hypothesis is that a switch from intravenous to oral antimicrobial therapy is non-inferior to standard intravenous therapy in patients with low-risk SAB. Therefore, the primary objective of the trial is to demonstrate, that oral switch therapy (…