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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…

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.

Hepcidin kinetics in hemodialysis patients.

Serum hepcidin levels are elevated in hemodialysis patients and may contribute to functional iron impairment and thus to ESA-resistance. Kinetics of hepcidin in hemodialysis patients has not been studied in detail. This study is designed to provide…

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…

The Fear F8ctor Study

To explore the effects of acute fear on the coagulation system while sitting still.

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…

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…

Flow augmentation study

Primary Objective: The primary objective of this study is to identify whether the Geko system can augment flow compared to IPCS in post-thrombotic limbs before after stenting.(group 1) In group 2 we want to identify whether the Geko with occluded…

A phase I, open-label, randomized, two period, two-way cross over study to assess the influence of a high-calorie, high fat meal on the bioavailability of a 40 mg extended release PHA 022121 oral formulation

In this study we will investigate the influence of a high-calorie, high-fat meal on the uptake, breakdown, and elimination of the study compound PHA-022121. We will also investigate how safe PHA-022121 is and how well it is tolerated when it is used…

A Phase I, two parallel arms, open label, randomized, two period, two-way cross-over study to assess the steady-state pharmacokinetics of a 40 mg PHA-022121 XR tablet administered once daily with the steady-state pharmacokinetics of two 10 mg PHA-022121 IR capsules administered twice daily (Arm 1) and to assess the steady-state pharmacokinetics of 40 mg PHA-022121 XR tablet administered twice daily with the steady-state pharmacokinetics of four 10 mg PHA- 022121 IR capsules administered twice da

In this study we will investigate how quickly and to what extent a formulation of the study compound PHA-022121 is absorbed, transported, and eliminated from the body. There are two compositions of the study compound: one with an extended release…

A phase I, open-label, single-dose, randomized, cross-over, 3 parts study to evaluate in healthy subjects the relative bioavailability of eltrombopag new capsule formulation (CPS) in comparison to the reference marketed film-coated tablets (FCT) (Part 1), the pharmacokinetic comparability of eltrombopag CPS and marketed FCT (Part 2) and the effect of food on the pharmacokinetics of eltrombopag administered as CPS (Part 3)

- To evaluate the relative bioavailability between the new eltrombopag capsule formulation (CPS) and the marketed tablet formulation (FCT) at single oral doses of 25 mg and 75 mg, in healthy subjects in the fasted state.- To evaluate the PK…

Assessing the fractional absorption of iron from edible insects

The primary objective is to assess the relative bioavailability of iron from insect added to either a high- or low-phytate meal in humans and its potential to provide bioavailable iron. The secondary objective is to determine whether addition of…