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Erythrocytapheresis versus Phlebotomy as maintenance therapy in patients with hereditairy hemochromatosis; a randomised, single blinded, sequential, cross-over trial

The primary objective of the study is to determine the gain in effectiveness of TE compared with P when applied to remove excess iron during maintenance therapy of HH patients.

The metabolic response during low-frequent and high-frequent neuromuscular electrical stimulation of the quadriceps muscles in patients with chronic obstructive pulmonary disease

Comparing the metabolic response (oxygenuptake and ventilation) and symptom perception (borgscores for dyspnoea and fatigue) between neuromuscular electrical stimulation with low-frequency and high-frequency.

Renal hemodynamic effects of aliskiren (rasilez) in comparison to ramipril (tritrace) in patients with overweight/obesity and hypertension

The primary objective of this study is to determine the effects of aliskiren, as compared to ramipril, on renal hemodynamics in overweight/obese and hypertensive patients.

The Neurobiological Basis of Disengagement:
A Mechanism Implicated in Visuospatial Attention.

Our primary objective is to provide a model which accounts for the inconsistencies in the pharmacological literature regarding the role of the noradrenergic and cholinergic system in visuo-spatial attention. Recently we started a University Medical…

Pharmacokinetics in Plasma and Saliva of a Single Dose Immediate- or Extended-Release Methylphenidate in Healthy Volunteers.

To establish the pharmacokinetic profiles of saliva and plasma concentration of 10 mg MPH-IR and 18 mg MPH-OROS in healthy volunteers; to investigate whether there is a correlation between saliva- and plasma levels of MPH-IR and MPH-OROS, and if…

Study of the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral dosing in healthy subjects including brain Serotonin Transporter (SERT) occupancy by Positron Emission Tomography (PET).

Primary:- to evaluate the safety and tolerability of the compound in different multiple dosing regimens in healthy subjects in different dosing regimensSecondary:- to characterize the pharmacokinetics of multiple oral doses of LY2878735 administered…

Validation study: a newly developed neuropathic pain Heat-Capsaicin-Warmth (HCW) sensitization model.

Primary:Part I:- to determine the effects of gabapentin and remifentanil on the evoked area of hyperalgesia, area of allodynia, pinprick hyperalgesia and background pain using a newly developed HCW sensitization modelPart II: - to determine…

Breakfast replacement by a low-glycemic index liquid formula in patients with diabetes mellitus type 2

Primary Objective: To determine the effect of breakfast replacement by a low-glycemic index liquid meal on fasting and postprandial glucose and insulin concentrationsSecondary Objective(s): To determine the effect of breakfast replacement by a low-…

A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosis

The objective of this pivotal study is to assess the PK and PD as well as safety and tolerability of RP103 compared to Cystagon® in patients with nephropathic cystinosis. Results of this Phase 3 study will be used to support the registration…

A Pharmacokinetic and Pharmacodynamic Comparison of Prasugrel and Clopidogrel in Low Body Weight versus Higher Body Weight Aspirin-Treated Subjects with Stable Coronary Artery Disease

The primary objective of this study is to demonstrate non-inferiority by pharmacodynamic (PD) analysis of the prasugrel 5-mg maintenance dose (MD) in aspirin-treated subjects <60 kg with stable coronary artery disease (CAD) versus the…

A Randomized, Placebo- and Active-Controlled, Double-Blind, 4-way Crossover Design, Thorough ECG Study of VX-770 in Healthy Adult Subjects

Part A:To evaluate the safety and tolerability of increasing doses of VX-770 up to 450 mg (q12h) in healthy male subjects.Part B:To determine if therapeutic or supratherapeutic systemic exposure to multiple doses of VX 770 prolongs the mean…

Evaluation of E7050 Pharmacokinetics after 100 mg Single Oral Doses Under Fed and Fasted Conditions and Characterization of E7050 Pharmacokinetics after 100 mg, 200 mg and 400 mg Single Oral Doses Under Fasted Condition in Healthy Subjects

Primary: * To determine the effect of food on the bioavailability of E7050 following oral administration of a tablet containing 100 mg E7050 with and without a standard low- or high-fat breakfast (Part A)* To characterize E7050 pharmacokinetics…

Tryptophan enriched diet to improve affective and cognitive functions in patients with multiple sclerosis

The purpose of this study is to test the acute effects of a TRP enriched meal in a dose-dependent manner in MS patients. The results of MS patients without mood disturbances (control group) will be compared to MS patients with mood disturbances (…

Comparison of two artificial pancreas systems for closed-loop blood glucose control versus open loop control in patients with Type 1 diabetes

Objective of the study is the comparison of two previously developed computeralgorithms for the artificial pancreas (closed loop). One algorithm developed by a researchgroup in Cambridge UK, and an algorithm developed by research groups in Padua and…

A phase I, open-label, two-stage, randomized, crossover, comparative pharmacokinetic and safety study of two formulations of CO-1.01 for injection in patients with advanced solid tumors.

Primary objective:•To compare the pharmacokinetic (PK) profiles of gemcitabine-5*-elaidate (parent compound) of two formulations of CO-1.01 in order to investigate whether the confidence interval (CI) for the ratio of the AUC0-* of the two…

A randomised, double blind, placebo-controlled cross-over study to investigate the effects of intravenous S(+)-ketamine on functional brain connectivity using fMRI in healthy volunteers.

By means of resting state network measurments using fMRI we hope to gain more knowlegde about the actions (for example as an analgesic) an side effects of S(+)-ketamine on the central nervous system at different doses. Also blood samples will be…

The influence of GINkGo biloba on the pharmacokinetics of the UGT substrate raltEgraviR (GINGER)

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.

The effects of Sokatin® on mood and cognitive function

The objective of the study is to investigate if daily oral intake of 500 mg Sokatin® improves mood and cognitive function in healthy subjects.

CNS drug effect profiling in adolescents: an educational class experiment using alcohol as a model.

- To educate adolescents about clinical drug studies by involving them as project team members and participants in a class experiment with negligible risk and minimal burden;- To educate adolescents about the effects of a low (*social*) dose of…

Assessment of next-morning driving performance after middle of the night administration of zolpidem tartrate sublingual tablet 3.5 mg in healthy adult volunteers: single-center, double-blind, randomized, placebo-controlled, four-way crossover study

The aim of the study is to assess the risk of impaired driving in the morning at 3 and 4 hours after a middle-of-the-night dose of zolpidem tartrate sublingual tablet 3.5 mg.