12 results
In subjects with T2DM, with inadequate glycemic control, who have a history or high risk of CV disease:Primary Objectives*to assess the effect of canagliflozin plus standard of care relative to placebo plus standard of care on CV risk as measured by…
The primary objective(s) of this study is:- To determine the relative bioavailability of etoricoxib 120 mg tablets manufactured at Frosst Iberica, Spain and Elkton, VA, USA.
To investigate the clinical pharmacokinetics of tobramycin and/or colistin after nasal administration. With this pharmacokinetic parameters the safety of this treatment can be investigated.
Primary objective: To determine the safety of once daily inhalation of the recommended daily dose of tobramycin with the Akita® and the PARI-LC® Plus nebulizer in patients with CF. Systemic absorption can be used as surrogate parameter for safety.…
The first objective to investigate is the pharmacokinetics of DP tobramycin using the Cyclops® at four different dosages. The other objective is the local tolerability of DP tobramycin using the Cyclops® at four different dosages.
Primary objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in…
Primary objectives:- To identify whether EBC can be used as a non-invasive method to measure the PK of salbutamol and tobramycin.- To determine whether the relationship in mild-moderate asthmatics between pulmonary lung function parameters and…
Primary objective: To study the pharmacokinetics of gentamicin, tobramycin, vancomycin and ciprofloxacin in morbidly obese patients and compare with normal weight patients. Secondary objectives: To assess the influence of covariates (such as TBW,…
Primary objectiveIn subjects with T2DM receiving standard of care but with inadequate glycemic control and at elevatedrisk of cardiovascular (CV) events to assess the effect of canagliflozin compared to placebo onprogression of albuminuria.Secondary…
The main objectives are:• To assess canagliflozin target (i.e. receptor) specific binding in vivo• To assess receptor occupancy of canagliflozin in vivo• To determine optimal scanning time in vivoTo explore the relationship between canagliflozin…
The main objectives are to investigate the pharmacokinetic properties of DP tobramycin via the Cyclops® at different dosages in children with CF, together with the local tolerability.
To determine the effect of Pre-OP, in addition to perioperative intravenous antimicrobial prophylaxis on the cumulative incidence of deep surgical site infections (SSI) and/or mortality within 30 days after surgery in patients undergoing elective…