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A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjects

The purpose of the study is to compare LA-EP2006 and Neulasta® with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called pharmacokinetics). It…

A randomized, open label, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 following a single subcutaneous injection by an autoinjector and by a pre-filled syringe in healthy male subjects

Primary objective:To demonstrate bioequivalence of GP2015 applied by an autoinjector (delta-GP2015_50) and a pre-filled syringe (PFS) as single subcutaneous injection of 50 mg to healthy adult male subjectsSecondary objectives- To study and compare…

Treatment in patients with recurrent infections and IgG Subclass Deficiency, and/or Deficient Anti-Polysaccharide Antibody Response.

The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…

Periodontitis and Rheumatoid Arthritis; a link by protein citrullination? A cross-over clinical trial

To assess periodontitis-with P. gingivalis in particular- as a pathogenic factor in disease progression of RA.

The influence of Raltegravir (MK_0518) on the pharmacokinetics of single-dose Lamotrigine in healthy male subjects (GRANOLA)

In vitro data indicate that raltegravir is not a substrate of UGT1A4 or UGT2B7, but there is no evidence that raltegravir itself does not influence metabolism of other agents mediated by either UGT1A4 or UGT2B7.

Reumates@work; An internet based cognitive behavioural programme to promote physical activity in children with Juvenile Idiopathic Arthritis (JIA).

To improve physical activity levels and physical activity patterns in children with JIA by means of cognitive behavioural training based on the social cognitive theory and the health promotion model, delivered by internet and supported by group…

Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy

The primary objective is:1. To investigate whether high frequency low dosage IVIg treatment is more effective than low frequency high dosage as maintenance treatment for CIDP. Secondary objectives are:2. To investigate whether high frequency low…

A Randomized, controlled, cross-over Study to assess Hypoallergenicity of an extensively hydrolyzed whey protein Infant formula in children with cow's milk allergy using amino-based infant formula as a reference.

The primary study objective is to assess the hypoallergenicity of an extensively hydroloyzed whey protein infant formula in children with cow's milk allergy.The second study objective is to assess the long-term effects on growth and tolerance…

A single-dose, open-label, randomized crossover study to assess the bioequivalence of darunavir 800 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg, in the presence of cobicistat 150 mg, administered as either a fixed-dose combination tablet or as separate agents in healthy subjects

The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…

Increasing plasma adrenaline levels through breathing techniques - an explorative study

Therefore, the primary objective of the present study is to investigate whether the hyper/hypoventilation or the strength ventilation technique accounts for the observed increase in plasma adrenaline levels. Furthermore, we want to determine whether…

A randomised controlled trial to evaluate the effect of gloves containing silver fibre on burden caused by Raynaud's phenomenon in patients with systemic sclerosis

To determine the efficacy of silver enhanced gloves in decreasing burden of Raynaud*s phenomenon in patients with systemic sclerosis.

*Differences in effect of treatment with mepolizumab and benralizumab on resident and inflammatory eosinophils"

To test the hypothesis: the mode of action of benralizumab being ADCC will target both resident and inflammatoryeosinophils whereas mepolizumab only targets inflammatory eosinophils. This will achieved by a head-to-headcomparison of the presence of…

Local Responses to Food Allergens in Eosinophilic Esophagitis: Mechanisms and Clinical Application

1. To investigate different modes of allergen administration to the esophageal wall, by testing the effect on visible mucosal changes2. To investigate which immune cells become activated after allergen provocation 3. To investigate whether the…

Bioavailability of phosphorus after oral intake of hypoallergenic infant formula with additional phosphate sources in healthy adult volunteers with a neutral stomach pH.

This study's objective is to assess the bioavailability of phosphorus after oral intake of a new hypoallergenic infant formula compared to the bioavailability of phosphorus after oral intake of the current hypoallergenic infant formula.

Bioavailability of phosphorus after oral intake of two hypoallergenic infant formulas in healthy adult volunteers with a neutral stomach pH

This study's objective is to assess the bioavailability of phosphorus after oral intake of a new hypoallergenic infant formula compared to the bioavailability of phosphorus after oral intake of another hypoallergenic infant formula.