32 results
Primary Objective: - to evaluate the pharmacokinetic (PK) parameters (AUC0-t, AUC0-inf, Cmax, C24hr, Tmax, and apparent t*) of MK-3682 and its circulating metabolites (IDX20664 and IDX23267), MK-5172, and MK-8742 following administration of two…
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.…
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…
1. To assess the effect of the switch from protease inhibitors to raltegravir on endothelial function. 2. To assess the effect of the intervention mentioned above on markers of endothelial function; immune activation; chronic inflammation; and, on…
In this trial will be investigated if a new formulation of valacyclovir, e.g. oral solution, is bioequivalent to valacyclovir tablets. This comparison will be made by determining pharmacokinetic parameters (AUC0-*, Cmax, and tmax) of both…
The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to…
Primary objective:To assess the bioequivalence of single dose STB after administration of standardized breakfast followed by a whole tablet (reference) and a crushed and suspended tablet (intervention I).To assess the bioequivalence of single dose…
- To compare the primary pharmacokinetic parameters AUC0-last, AUC0-*, and Cmax of MK-8228 after single dose administration of one tablet of 480 mg MK-8228 (test) and two tablets of 240 mg MK-8228 (reference) under fasting conditions.- To compare…
Primary objectiveTo determine the effect of multiple dose OME on the pharmacokinetics (AUC0-8h, Cmax, C8h) of BOC.Secondary objectives:To determine the effect of steady state BOC on the pharmacokinetics (AUC0-8h, Cmax, C8h) of multiple dose OME.To…
Primary objectiveTo determine the effect of steady state boceprevir on the pharmacokinetics (AUC0-12h, Cmax, C12h) of a single dose raltegravir.Secondary objectives:To determine the effect of a single dose raltegravir on the pharmacokinetics (AUC0-…
To assess periodontitis-with P. gingivalis in particular- as a pathogenic factor in disease progression of RA.
1º Is there a significant difference of more than 10% in the pharmacokinetic parameter AUC of the investigated antineoplastic drugs (as a surrogate parameter for the efficacy) in the presence and absence of NNRTIs and/or PIs?2º Are there clinically…
Primary objective:To assess the effect of multiple dose atorvastatin on the steady state pharmacokinetics of raltegravir and vice versa by intrasubject comparison in healthy subjects.• The comparison of steady state raltegravir (400 mg BID for 7…
To determine the relative bioavailability of ciprofloxacin oral suspension versus oral tablets in pediatric cancer patients, and to determine the absolute bioavailability of tablets and suspension utilizing the 100% bioavailability of intravenous…
Primary objective: To determine the pharmacokinetic profile of lopinavir and ritonavir in two differ-ent co-formulations (Lopimune granules and Lopimune tablets) after single-dose in HIV-negative, healthy adult subjects, and to compare this to the…
Primary objective: To evaluate the influence of fosamprenavir/ritonavir on single-dose pharmacokinetics of olanzapine in healthy volunteersSecondary objective: To evaluate the safety of fosamprenavir/ritonavir combined with single-dose olanzapine in…
This study involves research and the objective of this study is to evaluate how much and how fast TMC278 is absorbed into the body after administration as these concept pediatric formulations compared to when administered as the 25 mg TMC278 tablet…
To determine the effect of chronic use of ginkgo biloba on the single-dose pharma-cokinetics (AUC0-inf, AUC0-12, Cmax, C12) of raltegravir 400mg in healthy volunteers.
With this study we will investiagate the superiority of fecal clysma therapy (n=34 patients) above conventional therapy with the antibiotic vancomycin (n=34 patients) or bowellavage with conventional antibiotic therapy (n=34 patients).
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers