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A randomized, open-label, vehicle-controlled, parallel-cohort, dose-ranging study to explore the pharmacodynamics of topically applied imiquimod in healthy volunteers

Primary objective- To explore the pharmacodynamic effects of topically applied IMQ (in combination with or without TS) - To identify dose-response relationship of topically applied IMQ Secondary objective- To assess safety and tolerability of…

SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, TWO-PARTS, TWO-WAY CROSSOVER STUDY TO INVESTIGATE THE EFFECTS ON HEART RATE, BLOOD PRESSURE, AND PHARMACOKINETIC INTERACTIONS OF ACT-128800 COMBINED WITH A CALCIUM-CHANNEL BLOCKER OR A BETA-BLOCKER IN HEALTHY SUBJECTS

Primary:to investigate the effects on heart rate (HR) and rhythm of concomitant administration of the study drug with a calcium-channel blocker (CCB) or a beta-blocker (BB)Secondary:- to investigate the effects on blood pressure (BP) of concomitant…

A Phase I, open-label trial to investigate the pharmacokinetic interaction between TMC125 and two antifungal agents (fluconazole and voriconazole), all at steady-state in healthy subjects.

The objectives are:1. the effect of steady state concentrations of voriconazole and fluconazole on the steady-state pharmacokinetics of TMC125,2. the effect of steady-state concentrations of TMC125 on the steady-state pharmacokinetics of…

Effect of colostrum on immune function after intense strenuous exercise in well-trained cyclists.

The primary objective of this study is to evaluate the effect of colostrum supplementation on the immune response after intense strenuous exercise.The secondary objective is to study the effect of intense strenuous exercise - and its possible…

Evaluation of Pharmacokinetics, Relative Bioavailability, and Safety of PA-101 in Healthy Subjects, Patients with Systemic Mastocytosis, and Patients with Allergic Asthma

To evaluate the plasma pharmacokinetic properties and safety of the research medication in healthy volunteers and in Patients with Systemic Mastocytosis and Allergic Asthma.

The Dynamics Study:
Influence of NaCl intake on Microcirculation and Immune sytem

In this study we aim to elucidate effects of dietary sodium intake on:1. Microcirculation by studying the capillary network during high and low sodium conditions.2. Adaptive and innate immune system by studying circulating T-lymphocyte…

Probiotics in atherosclerosis: a pilot study

The objective of the study is to see whether oral administration of probiotics can modulate certain immunological markers which are associated with accelarated atherosclerosis in patients with ANCA associated vasculitis.

Safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens in patients with rheumatoid arthritis treated with anti TNF-* antibodies (adalimumab) or anti B cell therapy (Rituximab).

To assess the effect of adalimumab and rituximab on the safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens.

A Phase I, open label, randomized, crossover trial in healthy subjects to investigate the pharmacokinetic interaction between didanosine and TMC114, coadministered with low-dose ritonavir, at steady-state.

The primary objectives are:* to determine the effect of steady-state concentrations of TMC114 coadministered with a lowdose of ritonavir on the steady-state pharmacokinetics of ddI,* to determine the effect of steady-state concentrations of ddI on…

Phase I, open-label, 3-way crossover trial in healthy male subjects to
evaluate the pharmacokinetics of TMC114 and TMC41629 after a
single oral dose of 2 controlled-release coformulations as compared to
an immediate-release coformulation of TMC114/TMC41629

This is a scientific research with the aim to investigate the bioavailability of a combination of the drugs TMC114 and TMC41629 . The three dosage forms, each only once ingested. In addition, even in this study the safety of the use and possible…

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…

A randomized, open-label, two-period, two-sequence, single-dose, cross-over study to compare the pharmacokinetics, safety, and tolerability of the auto injector and pre-filled syringe of SB4 in healthy male subjects.

Benepali® and Brenzys® are approved as drugs that are administered as a subcutaneous (under the skin) injection using a pre-filled syringe. With a pre-filled syringe the drug is delivered through a needle which is inserted manually into the skin.…

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…

Influence of saltintake on Microcirculation and immune System

In this study we aim to elucidate effects of dietary sodium intake on:1. Body weight and blood pressure2. Microcirculation by studying the capillary network during high and low sodium conditions.3. Adaptive and innate immune system by studying…