37 results
The aim of this study is to determine whether subcutaneous administration of insulin detemir, as compared to NPH insulin, leads to a more pronounced effect on brain glucose metabolism and blood flow in brain regions associated with appetite…
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…
We will develop a bi-daily low-dose metronomic treatment schedule with paclitaxel in a convenient oral formulation and test whether this therapy has significant anti-angiogenic and anti-tumor activity.
- evaluation of the safety of extended use of ModraDoc006/r - provide longterm access to ModraDoc006/r treatment for patients who have completed a phase I trial with ModraDoc006/r and who might have benefit from longterm treatment with weekly…
Primary objective: to investigate the effect of treatment with the GLP-1ra exenatide on the awareness of and counterregulatory hormone responses to hypoglycemia in people with type 1 diabetes and impaired awareness of hypoglycemia. Secondary…
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-…
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…
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…
Primary objective: to confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. Secundary objective: to compare…
Pharmacology of rapid-acting insulin injected by needle-free jet-injection in patients with diabetes
To compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected with jet-injection to that of the same insulin injected with a conventional pen prior to a standardised meal.
To standardize the procedures and analyses to support evaluation of glucose dependent insulin secretion in Type 2 Diabetes Mellitus in subjects with Type 2 Diabetes.
To confirm the effect of continious subcutaneous insulin infusion (CSII treatment) with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 diabetes Mellitus, using a…
(1) To phenotype chronic low back pain patients in terms of endogenous modulation of pain, central sensitization/facilitation, and the presence of a neuropathic pain component;(2) To assess the effect of a three-month treatment with tapentadol on…
* To determine the DLT and the MTD/RP2D of docetaxel as ModraDoc006/ritonavir that can be administered safely to patients with NSCLC in a bi-daily weekly schedule, following platinum doublet first-line treatment.
This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion, insulin bolus regimen and…
Primary objective:To compare the effect of multiple dose atazanavir/cobicistat on the multiple dose phar-macokinetics of daclatasvir with the effect of atazanavir/ritonavir on the multiple dose of daclatasvir by intra-subject comparison in healthy…
(1) To phenotype fibromyalgia patients in terms of endogenous modulation of pain, central sensitization/facilitation, the presence of a neuropathic pain component and small fiber neuropathy;(2) To assess the effect of a three-month treatment with…
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…
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 compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of…