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A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Fasting Conditions
This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.
Final objective of critical care is no longer only survival. The role of medical and paramedical teams should also be to restore functional capacities, autonomy and quality of life. What has been call "intensive care unit - acquired weakness" (ICU-AW) is associated to acute and long term increased mortality, prolonged ICU and hospital stay, prolonged duration of mechanical ventilation, altered quality of life in survivors and increased health-related costs. In order to target efficient secondary prevention and early rehabilitation, prompt identification of muscle weakness is crucial. Several methods, aiming to assess muscle mass, muscle strength or physical function, are described. Manual muscle testing using the Medical Research Council (MRC) scale is still the most commonly utilized tool to diagnose ICU-AW (MRC <48/60). Dynamometry is an objective alternative and one of the most accurate clinimetric tool to assess muscle strength. Literature is overflowing with insufficiently standardized dynamometry data. Using the investigator's published standardized protocol of quadriceps strength (QS) assessment, this observational study aim to describe physical performances of CC patients and thus to define the weakest ones, by comparing them to surgical and healthy subjects.
The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.
This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan in healthy male subjects.
Vasopressin has primarily been considered to be a water and osmosis regulating hormone that mediates its effects on renal aquaporin channels. Recent data suggest that vasopressin, through its V2 receptor, may also modulate sodium homeostasis. The purpose of this human physiology study was to test whether antagonism of the V2R alters urine sodium excretion in normal healthy volunteers.
Dietary protein consumption maximizes the anabolic response during resistance training (RT) by triggering muscle protein synthesis and providing the indispensable amino acids for a net positive protein balance. Leucine is considered the key amino acid in this process, suggesting that differences in protein quality may influence RT-induced gains in muscle mass and strength. In general, plant-based protein sources have lower leucine concentrations than animal-based protein sources and human skeletal muscle. In this respect, despite acute evidence on lower anabolic properties of plant- vs. animal-based protein, the effects of an exclusive plant-based dietary protein diet on RT-induced adaptations are currently unknown.
A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drugs interaction between Telmisartan, Amlodipine and Hydrochlorothiazide in healthy male volunteers
This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.
This is a 12-week, randomized, double-blind, single-dose pharmacokinetic (PK) study. Approximately 114 healthy male participants (screening occurred within 28 days prior to dosing) will be randomized 1:1:1 to either TRS003, China-approved bevacizumab, and US-licensed Avastin® groups. Study drug will be dispensed as a single 3 mg/kg dose for intravenous infusion within 90 minutes. PK and immunogenicity samples will be collected and safety will be assessed. The primary objective of this study was to demonstrate pharmacokinetic similarity between TRS003, China-approved bevacizumab and US-licensed Avastin®, as measured by AUC0-inf in healthy male participants after a single 3 mg/kg dose.