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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 Phase 3 clinical study to determine the pharmacokinetics, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in subjects diagnosed with von Willebrand disease

Primary objective:• Assess the pharmacokinetics (PK) of rVWF:rFVIII and rVWF, and to assess the safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding events in subjects with severe hereditary VWDSecundary objectives:• Compare the…

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

Primary Objective:To compare the efficacy of pacritinib with that of Best Available Therapy (BAT) in patients with PMF, PPV-MF, or PET-MF; the efficacy measure for this analysis is the proportion of patients achieving a * 35% reduction in spleen…

Single center, randomized, double-blind, 3-period, 3 treatments, 3 way crossover pharmacokinetics (PK)/pharmacodynamics (PD) trial to assess PK, PD, safety and tolerability of MYL-1401H after single subcutaneous injection at one dose level (2 mg) comparing to an EU and US marketed drug product (NEULASTA®) in healthy volunteers.

The purpose of the study is to investigate how quickly and to what extent MYL-1401H is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to Neulasta® EU and US. It will also be investigated what the effect is of MYL…

A Randomized Controlled Phase 3 Study of Oral Pacritinib versus Best Available Therapy in Patients with Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

The primary objective is to compare the efficacy of two dose-schedule arms(s) of pacritinib (pooled once daily [QD] and twice-daily [BID] dosing arms) with that of best available therapy (BAT) in patients with thrombocytopenia and primary…

A randomized, 2 part, 4-treatment, 2-way cross-over study in healthy volunteers to compare the pharmacokinetic and pharmacodynamics profiles of 1 *g/kg of DA-3880 and EU sourced AND EU Aranesp® (AMGEN) after single intravenous or subcutaneous administration

The purpose of the study is to investigate to what extent DA-3880 is absorbed and eliminated from the body (this is called pharmacokinetics) as compared to the above mentioned Aranesp® formulation. In addition, the effect DA-3880 on the number of…

Protocol CV185074: evaluation of multiple dose pharmacokinetics and pharmacodynamics of apixaban and rivaroxaban in healthy subjects

Primary:- to assess the multiple-dose pharmacokinetics of apixaban and rivaroxaban - to compare plasma concentration peak to trough ratio (Cmax/Cmin) of rivaroxaban to apixaban Secondary:- to assess the multiple dose pharmacodynamics (anti-Factor Xa…

A Phase 1 Study to Compare the Pharmacokinetics of CAL-101 Capsules to Tablets in Healthy Male Subjects.

Primary: to evaluate the pharmacokinetics of a single 100 mg dose of CAL-101 administered as a capsule (unmicronized formulation), a capsule (micronized formulation) or a tablet in normal healthy male subjectsSecondary: to evaluate the safety of a…

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.

Randomised trial to investigate possible differences in biological availability and effectiveness between vitamin K solution in oil and vitamin K tablets.

1. Determining whether or not the vitamin K tablets have the same biological availability in humans as the vitamin K solution has.2. Determining whether or not the vitamin K tablets are as effective as the vitamin K solution is.

EDOXABAN SWITCHING STUDY FOR APIXABAN

Primary :To evaluate the prothrombin time (PT) in healthy volunteers treated with edoxaban alone or preceded by apixaban.Secondary : To assess the effect of edoxaban alone or preceded by apixaban on additional pharmacodynamic (PD) assays: activated…

Effects of low-dose aspirin taken at bedtime vs. on awakening on circadian rhythm of platelet function in healthy subjects

To study the effect of 80 mg aspirin intake at bedtime compared with 80 mg aspirin intake on awakening on circadian rhythm of platelet function in healthy subjects.

A randomized, double-blind, placebo-controlled, 4-period cross-over drug-drug interaction study to evaluate the effect of sugammadex and aspirin on platelet aggregation and coagulation parameters in young healthy male volunteers

To investigate the potential of an interaction between 4 mg/kg sugammadex and aspirin on platelet aggregation using collagen-induced whole blood aggregometry in young healthy male volunteers.

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…

N-Acetylcysteine for Treatment of Sickle Cell Disease

STUDY OBJECTIVESTo determine whether NAC therapy results in decreased red cell PS exposure, endothelial activation, inflammation, and reduction clotting activation in the steady state.

Randomized, Double-blind, Placebo-controlled, Crossover Design, Efficacy and Safety
Study with PA101 in Patients with Indolent Systemic Mastocytosis

Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…

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, Active-controlled, Phase 3 study evaluating the Efficacy and Safety of ABP 959 compared with Eculizumab in Adult Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Primary Objective: The primary objective for this study is to evaluate the efficacy of ABP 959 compared with that of eculizumab based on control of intravascular hemolysis.Secondary Objective: The secondary objective is to assess the safety,…

Comparison of different transfusion strategies for red blood cell transfusion dependent MDS and MPN patients - a cross-over study with remote patient monitoring

Compare the effect of three different RBC transfusion strategies* (Standard of care (SoC), SoC+1 and SoC+2**) on heart rate in a population of chronically transfused patients (with on average at least 1 RBC transfusion each 8 weeks as personal…