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ABILITY OF PROTHROMBIN COMPLEX CONCENTRATE (COFACT ®) TO REVERSE THE ANTICOAGULANT EFFECT OF NOVEL ANTITHROMBOTIC AGENTS

Study questionWhat is the effect of a single administration of prothrombin complex concentrate (CoFact) on the anticoagulant effect of a novel oral thrombin inhibitor (Dabigatran) and a novel oral factor Xa inhibitor (Rivaroxaban) in healthy human…

Single-dose, randomized, double-blind, two-way crossover study for the demonstration of pharmacodynamic equivalence of enoxaparin (100 mg/mL) 100-mg subcutaneous injection. Manufactured by Rovi (Spain) to Clexane (100 mg/mL) 100-mg subcutaneous injection manufactured by Sanofi (EU) in healthy volunteers.

The purpose of the study is to investigate the effect on the body of enoxaparin manufactured by the Sponsor (this is called pharmacodynamics) and to compare it with the pharmacodynamic effect of Clexane®. In addition, it will be investigated to what…

A multi-centre, comparative, double blind, randomised cross-over trial investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A

Primary objectiveTo evaluate and compare the single-dose pharmacokinetic of turoctocog alfa pegol from the pivotal process with turoctocog alfa pegol from the commercial process, each given as intravenous administrations of 50 U/kg to patients with…

A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Three-way Crossover Trial to Evaluate the Efficacy and Safety of Two Dose Levels of KVD900, an Oral Plasma Kallikrein Inhibitor, for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients with Hereditary
Angioedema Type I or I

Primary Objective: To demonstrate the clinical efficacy of KVD900 compared with placebo for the on-demand treatment of HAE attacks.Secondary Objective: To investigate the safety and tolerability of KVD900.

Health effects due to inhalation of ultrafine particles in healthy volunteers. Multiple short-term exposures to UFP near Schiphol Airport.
A cross-over study

We hypothesize that the toxic potency of UFP from air traffic is comparable to road traffic after inhalation by healthy humans. Therefore, we aim to:* Identify acute effects of short-term inhalation of ultrafine particles right next to Amsterdam…