6 results
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…
The objective of this exploratory study is to investigate the acid neutralisation action of sodium alginate oral suspension versus placebo liquid, within the stomach and to assess suitability and robustness of the pH monitoring methodology.
This protocol is designed to determine the safety, tolerability, and efficacy of SGI-110 in combination with irinotecan in previously treated patients with metastatic colorectal cancer who progressed on irinotecan.
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 (…
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 (…
The primary objective of this confirmatory study is to confirm the acid neutralisation action of Gaviscon Double Action Liquid versus placebo liquid, within the stomach.