104 results
Primary : To assess the effect of multiple doses of rifampicin on the single-dose pharmacokinetics (PK) of tasquinimodSecondary : To assess the safety and tolerability of multiple doses of rifampicin with a single dose of tasquinimod
Primary:- To assess the effect of multiple doses of ketoconazole on the single-dose pharmacokinetics (PK) of tasquinimod.Secondary:- To assess the safety and tolerability of multiple doses of ketoconazole with single doses of tasquinimod.
to offer continuation of BIBF 1020 treatment for patients with IPF who have completed a prior clinical trial with that drug.establish the long term tolerability and safety profile of BIBF 1120 in IPF.
The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in…
Primary: to assess the bioequivalence of LH after administration of the freeze-dried (FD) Luveris formulation (Reference) versus the liquid formulation of Luveris in the pre-filled pen (Test) based on the PK parameters AUC0-t and Cmax of serum LH.…
The objective of the trial is to confirm efficacy and a favorable benefit-risk ratio for BIBF 1120 in the treatment of IPF at the dose of 150 mg bid compared to placebo.
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…
The primary objective of this study is to compare the overall survival (OS) of ramucirumab DP administered in combination with docetaxel versus docetaxel with placebo as therapy for patients with Stage IV non-small cell lung cancer (NSCLC) who have…
The aim of this extension trial is to provide BIBF 1120 treatment for all patients who have completed the 52 weeks treatment period and the follow up period in the phase III placebo controlled parent trial 1199.34, who may have experienced benefit…
Primary ObjectivesTo quantify BCT197, and to identify and quantify its metabolites in plasma, urine, and feces.To determine the pharmacokinetics of total 14C-radioactivity in blood and plasma, and of any important metabolites in plasma and excreta.…
The purpose of the study is to evaluate the adhesiveness of two different patch formulations of rotigotine. This study is not intended to improve the health, but is necessary for the further development of the rotigotine patches
The main purpose of the study is to investigate whether the transdermal patch system HP-3070 shows blood concentrations of asenapine that make this route of administration suitable for clinical use. The transdermal route of administration is likely…
The purpose of the study is to compare the hemodynamic effects (study of blood flow or circulation, such as blood pressure, heart rate, cardiac output (the volume of blood being pumped by the heart) and glomerular filtration rate (flow rate of…
Primary objective: Safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate RA.Secondary objectives: Pharmacokinetics, pharmacodynamics, including explorative biomarker assessments and efficacy of…
The primary objective of this study is to evaluate the hypothesis that cixutumumab given in combination with cisplatin and pemetrexed is superior to cisplatin and pemetrexed as first-line therapy for patients with advanced nonsquamous non-small cell…
OBJECTIVES of the Study:Primary ObjectiveTo evaluate if the addition of ibrutinib to R-CHOP prolongs event-free survival (EFS) compared withR-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.Secondary ObjectivesTo compare ibrutinib in…
During this study it will be investigated what the effect is of multiple doses of CBD on the absorption and elimination from the body (this is called pharmacokinetics) of clobazam, stiripentol or valproate. It will also be investigated what the…
The purpose of the study is to investigate to what extent GWP42003-P might lead to withdrawal effects after several weeks of dosing. Withdrawal effects are the signs and symptoms that can occur upon the abrupt discontinuation of some medications or…
Primary Objectives1. To assess the safety and tolerability of ascending doses of a single IV injection of OTL-0382. To assess the efficacy of ascending doses of a single IV injection of OTL-038 in detecting ovarian, renal cell and endometrial cancer…
1. To assess safety of different doses of a single iv injection of SGM-1012. To assess the performance of SGM-101 in the intraoperative detection of colorectal or pancreas cancer by:a. Tumor-to-background ratio (TBR);b. Concordance between…