66 results
The primary objective of this study is to quantitatively determine the pharmacokinetics (absorption, distribution, metabolism and excretion) of docetaxel (as ModraDoc003 10mg tablets) after administration of a single dose of oral docetaxel in…
Primary Objective:To assess the effect of UT-15C sustained release (SR) tablets on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary objective:To…
The key objective of this study is to assess next-day residual effects of MK-4305 (20 and 40 mg) via driving performance after 1 day of dosing and after 8 days of dosing.
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 is a proof-of-efficacy, dose finding study of LCI699 in patients with mild-to-moderate uncomplicated essential hypertension in order to assess whether the BP effect, safety and tolerability of LCI699 as compared to those of placebo…
The primary objective is to determine the maximum tolerated dose (MTD) of docetaxel (as ModraDoc001) that can safely be administered to patients with cancer in a bi-daily weekly schedule.
To assess safety and tolerability of EFI patients with PAH.
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 purpose of the study is to investigate how quickly Danoprevir is absorbed and the extent of absorption and elimination from the body (this is called pharmacokinetics and bioavailability) when it is administered intravenously (IV) or orally alone…
- To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan to EFI in patients with PAH.- To evaluate the safety and tolerability of switching from Flolan to EFI in patients with PAH.- To evaluate the…
Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…
To determine whether aleglitazar reduces cardiovasculair mortality and morbidity (defined as non-fatal myocardial infarction (MI) and non-fatal stroke) in patients with a recent ACS event and type 2 diabetes.
Primary Objective: To assess the effect of multiple oral doses of atazanavir 300 mg + ritonavir 100 mg once daily on the PK of BMS-790052 at steady state in healthy subjects.Secondary Objective(s): To assess the safety of multiple oral doses of BMS-…
Subjects randomized to the placebo treatment are unlikely to benefit from the study. However, OAB is not a life-threatening disease and it is not expected that a 12 to 15 week exposure to placebo treatment will have a negative impact on disease…
(1) To assess [11C]laniquidar plasma and brain kinetics in healthy volunteer(s), including assessment of the presence of radioactive metabolites in plasma. (2) To develop a tracer kinetic model for [11C]laniquidar in humans. (3) To determine intra-…
To quantitatively determine the absorption and excretion of docetaxel (as ModraDoc005 10 mg tablets) after administration of a single low dose and a single high dose of oral docetaxel in combination with ritonavir.
The primary objective of the study is to determine if the treatment of AMG 479 at 12 mg/kg and/or 20 mg/kg in combination with gemcitabine improves overall survival as compared with placebo in combination with gemcitabine in subjects with metastatic…
To suppress low-level viremia to a level below 50cp/mL in patients using cART by switching their current non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI to DRV boosted with ritonavir (RTV) (DRV/r). Secondary objectives are to reduce the…
To determine the maximum tolerated dose (MTD), dose limiting toxicities (DLT), and optimal dose of docetaxel that can safely be administered to patients with cancer in a weekly schedule. amendment 1The objective of the first amendment is to…
The primary objective of this study is to evaluate the safety and antiviral efficacy, defined as the percentage of subjects with sustained virologic response 12 weeks post-dosing (SVR12; HCV RNA < LLOQ 12 weeks after the last dose of study…