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Filter by:Low level intervention health products clinical trial, fourth phase, non-commercial research. Dissertation of COMPLUTENSE UNIVERSITY of Madrid. Principal Investigator of this clinical trial: Ms. LETICIA CARMEN SIMÓN LÓPEZ Collaborative investigators: Dr. DOLORES OCHOA-MAZARRO (principal investigator of bioequivalence clinical trial), and Sir. SERGIO LUQUERO-BUENO (collaborative researcher) The setting is Clinical trials Unit of Clinical Pharmacology Department. LA PRINCESA HOSPITAL of Madrid. Research Ethical Committee of LA PRINCESA HOSPITAL of Madrid. Any person will monitor this clinical trial because the sponsor and principal researcher are the same person. Nevertheless, an adherence to this protocol will ensure by principal researcher and co-researchers. The three interventions are: 1. To Apply local dry heat. 2. To apply high tourniquet pressure. 3. To apply both of them. (Dry heat and high pressure) The common comparator: Current Clinical practice for peripheral venous catheterization. The main hypothesis: The number of attempts of success venipuncture at first time are influenced by any of the interventions applied before. The main goal: To identify the most effective intervention of applying dry local heat and/or high tourniquet pressure in relation of number success venipuncture attempts, compared to current clinical practice. Design: An experimental, randomized study which is controlled with current clinical practice to insert a peripheral vein catheter. It is an incomplete cross-over clinical trial, with three arms which are involved interventions and a common comparator. Population: Adult healthy subjects. Sample size: It is required to enroll 54 subjects with a 95% of level of confidence and 80% level of power. Main variable: Succeed peripheral vein catheter insertion at first attempt. Effectiveness assessment: The optimal effectiveness is considered when vein cannulation success at first attempt exceeds 95% applying any of the interventions. Planned date to address: It is planned to carry out around June and/or July of 2017 for the main variable.
The purpose of this study was to examine the acute endothelial, cardiovascular, and performance responses to L-arginine by assessing flow-mediated dilation (FMD) and heart rate variability (HRV) both before and after resistance exercise to fatigue. Thirty (15 male, 15 female) physically active participants volunteered for a randomized, cross-over, double-blind, placebo- controlled clinical trial. Participants completed five sets of elbow extension-flexion exercise after consumption of either 3 g of placebo or 3 g L-arginine.
The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement of BMS-986142 in healthy subjects.
The purpose of this study is to investigate the bioequivalence of improved and current orally disintegrating E2020 10 mg tablets as a single dose in Japanese healthy adult males for each of two administration methods (with/without water).
The purpose of this study is to confirm bioequivalence between E2020 dry syrup 1% form (0.5 g), given either with 200 mL of water or suspended in 20 mL of water, and E2020 film-coated tablet (5 mg) in Japanese healthy adult males.
This is the investigatory study to find out metformin's pharmacokinetics, pharmacodynamics and drug-drug interactions classifying the group by MATE1 genotype in healthy volunteers. The investigators will apply ranitidine and verapamil to the drug interaction study of metformin.
Primary objective: - To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo. Secondary objectives: - To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults. - To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.