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Effect of Carbon Dioxide Enriched Ambient Air on Pharmacokinetics and Deposition In Bronchiectasis Patients Using Tobramycin Inhalation: A proof of concept study.

1. To asses (with planar imaging) whether SPECT/CT scan are feasible in assessing pulmonary deposition of inhaled tobramycin.2. To evaluate the effect of CO2 enriched ambient air on deposition of inhaled tobramycin in bronchiectasis patients.3. To…

Neuro-cognitive effects of tyrosine supplementation in healthy older adults:
A fNIRS-EEG study

We aim to assess the effects of tyrosine supplementation on prefrontal brain activation, as measured by a combination of fNIRS and EEG, during response inhibition and working-memory performance in older adults. We will also assess whether…

Pharmacokinetics of levetiracetam after rectal administration in healthy volunteers

Comparison of single-dose pharmacokinetics of levetiracetam after rectal versus oral administration at healthy volunteers.

A First-in-Human, randomized, double-blind, placebo-controlled ascending dose study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy subjects.

To investigate the safety, tolerability and efficacy of STR-324 infusions in healthy subjects.Primary objective (Parts 1 and 2)* To assess and characterise the safety and the tolerability of STR-324, over a 4-hour (Part 1) and a 48-h infusion (Part…

An open-label randomised cross-over study to evaluate the albuminuria lowering effect of dapagliflozin, exenatide and their combination in patients with type 2 diabetes

The main objective of the study is to determine the albuminuria lowering effect of the GLP1-RA exenetide, SGLT-2 inhibitor dapagliflozin and their combination in patients with type 2 diabetes and micro- or macroalbuminuria.Secondary objectives are…

Effect of High-volume Online hemodiafiLtration on intra-diaLytic hemodynAmic (iN)sTability and cardiac function in chronic hemodialysis patients (the HOLLANT study)

This study aims at improving the knowledge concerning HV-HDF and thus helps to tailor the optimal ERRT for each individual patient.The following hypotheses will be tested:1. Intra-dialytic hemodynamic stability is better preserved during HV-HDF as…

Randomized, Blinded, 2 stage, 2-way Crossover Bioequivalence Study of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel Administered as a Single Application of 125 mg in Healthy Subjects

This study will compare the study compound Mentholatum 10% w/w Ibuprofen Gel to a similar product, which is already on the market in UK called Ibuleve Maximum Strength Gel. The purpose of the study is to compare these two gels in how quickly and to…

Single-center, randomized, double-blind, single-dose, 3-way crossover study to compare the effects of daridorexant and placebo on postural stability, the auditory awakening threshold, and cognitive function in the middle-of-the-night following evening administration to healthy adult and elderly subjects

To evaluate the pharmacodynamic (PD) effects of daridorexant 25mg, 50mg, and placebo in the middle-of-the-night.

A Phase III Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel with or without the PARP Inhibitor Veliparib (ABT-888) in Her-2 Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer

The primary endpoint is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin (C) and paclitaxel (P) compared to placebo with C/P in subjects with a BRCA1 and/or BRCA2 Mutation and HER2-Negative Metastatic or…

A trial to assess the injection site pain experience of excipient solutions relevant for subcutaneous injection

The primary objective is to assess, in healthy subjects with a body mass index (BMI) greater than or equal to 25.0 kg/m2, the injection site pain experience of 9 excipient solutions (Trial Products 4 to 12), intended to be used in future…

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Adult Participants to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Co-administration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Con

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

Exploratory study into the effect of salt supplementation in Gitelman syndrome

To determine the effect of salt (NaCl) supplementation on (1) physiological parameters (such as serum potassium) and on (2) clinical signs and symptoms and quality of life.

A bridging trial to compare the pharmacokinetics of Glepaglutide (ZP1848) after a single subcutaneous administration by vial/syringe and by autoinjector in healthy subjects: a phase 1, randomized, open-label, three-way, reference-replicated crossover trial

- To compare the pharmacokinetics (PK) of glepaglutide after a single subcutaneous (SC) administration by vial/syringe and by autoinjector.- To evaluate the safety and tolerability of glepaglutide following SC dosing in healthy subjects.

A Single-Dose, Open-Label, Randomized, Replicate Crossover Pivotal Bioequivalence Study in Healthy Subjects to Assess the Bioequivalence of Darunavir 675 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide 10 mg in the Presence of Cobicistat 150 mg when Administered as a Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared to the Coadministration of the Separate Agents (Darunavir, Cobicistat, and Emtricitabine/Tenofovir Alafenamide), Under Fed Conditions

- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…

DIStal versus COnventional RADIAL access for coronary angiography and
intervention: a randomized multicenter trial

The objective of this study is to demonstrate the superiority of Distal Transradial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO) using the 6Fr Glidesheath Slender (GSS).

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAR443060 in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…

Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson*s Disease patients.

Primary ObjectivesAssess whether the finger tapping task endpoints:• Differentiate between ON and OFF states in PD patients• Correlate with the MDS-UPDRS part III total score• Differentiate between placebo and levodopa/carbidopa treatmentSecondary…

Randomized, double-blind, placebo-controlled single ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effects of YTX-7739, a novel oral inhibitor of Stearoyl-CoA-desaturases, in healthy volunteers

* Part A: To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing doses of YTX-7739 in healthy subjects. * Part B: To study the effect of food on pharmacokinetics of YTX-7739 in a selection of subjects who…

A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the effects of evolocumab added to standard lipid-lowering therapy on fasting and post fat load lipids in patients with Familial Dysbetalipoproteinemia.

To evaluate the effect of 12 weeks subcutaneous evolocumab (140 mg pre-filled pen every 2 weeks) compared to placebo on post fat load non-HDL-C levels in 30 subjects with FD, in a multicenter, randomized, placebo-controlled, double-blind, crossover…

An Open-label, Randomized, Crossover, Single Ascending Dose Pharmacokinetic Study of Continuous Subcutaneous Infusion of Lenalidomide Compared with Revlimid® Oral Capsules in Healthy Adult Male Subjects

The purpose of this study is to investigate how quickly and to what extend lenalidomide is absorbed and eliminated from the body (this is called pharmacokinetics). In this study the pharmacokinetics will be compared when lenalidomide is administered…