11 results
For Part A: the purpose of this part is to investigate the effect of multiple oral doses of the new study drug on how quickly and to what extent glimepiride is absorbed and eliminated from the body (this is called pharmacokinetics), if glimepiride…
The objective of the current study is to investigate the efficacy, safety and tolerability of BI10773 (25mg once daily) compared to glimepriride (1-4mg daily) given for 104 weeks with a 104-week extention period in patients with type 2 diabetes…
5.1 Study hypothesisThe primary study hypothesis states that oral treatment with itraconazole will reduce the epistaxis severity score (ESS) due to the anti-angiogenic effects of itraconazole.5.2 Research question and primary outcomeWhat is the…
CAROLINA studyThe aim of the present study is to investigate the long*term impact on CV morbidity and mortality and relevant efficacy parameters (HbA1c, fasting plasma glucose, treatment sustainability) of treatment with linagliptin in a relevant…
Primary Objective* To evaluate the antitumor efficacy of PO single agent CO-1686, as measured by ORR, when administered to patients with EGFR mutated, centrally confirmed T790M positive and T790M negative advanced NSCLC after tumor progression on 1…
- To assess the effect of food (high-fat) on the bioavailability and pharmacokinetic (PK)- profile of a solid dosage formulation of JNJ-67953964.- To assess the effects of repeated QD administration of 200 mg of itraconazole (steady state) on the…
Primary objective: What are the long-term effects (i.e. after 8-week drug exposure) of the DPP-4i linagliptin versus the SU derivative glimepiride on fasting and postprandial renal hemodynamics (glomerular filtration rate (GFR)/ effective renal…
The purpose of this study is to investigate how quickly and to what extent GS-4224 is absorbed and eliminated from the body. We study this when the study compound is administered alone and together with compounds that influence the activity of a…
In this study we will look at how quickly and to what extent the study compound MEN1611 is absorbed, transported, and eliminated from the body (this is called pharmacokinetics) and how this is influenced by the approved drug itraconazole fluvoxamine…
The study will be performed in 2 cohorts, Cohort 1 and Cohort 2. In Cohort 1, it will be investigated what the effect is of itraconazole on how quickly and to what extent APX001 is absorbed and excreted by the body (this is called pharmacokinetics…
The purpose of this study is to investigate the effect of multiple doses of itraconazole on how quickly and to what extent the new compound PHA-022121 is absorbed into the body and eliminated from the body (this is called pharmacokinetics). It will…