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A Safety Study In Healthy Volunteers To Evaluate Safety, How Fast The Drug Is Absorbed, And The Side Effects Of The Drug In Humans PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest A Safety Study In Healthy Volunteers To Evaluate Safety, How Fast The Drug Is Absorbed, And The Side Effects Of The Drug In Humans articles that have been published worldwide.
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Single- and Multiple-dose Pharmacokinetics and Safety of Pimodivir, a Novel, Non-Nucleoside Polymerase Basic Protein 2 Subunit Inhibitor of the Influenza A Virus Polymerase Complex, and Interaction With Oseltamivir: A Phase 1 Open-Label Study in Healthy Volunteers.
Evaluate the drug-drug interaction between pimodivir, a novel, non-nucleoside polymerase basic protein 2 (PB2) subunit inhibitor of the influenza A virus polymerase complex, and oseltamivir, to assess the feasibility of this combination therapy. Furthermore, single- and multiple-dose pharmacokinetics and safety of pimodivir in healthy volunteers were assessed.
Denosumab is a fully human monoclonal antibody against receptor activator of nuclear factor kappa-B ligand, a cytokine essential for the formation, function and survival of osteoclasts. This study assessed the pharmacokinetics, pharmacodynamics, safety and tolerability of single-dose denosumab (60 and 120 mg) in healthy Chinese volunteers.
Rearranged during transfection (RET), a neuronal growth factor receptor tyrosine kinase, regulates the development of the sympathetic, parasympathetic, motor, and sensory neurons in the enteric nervous system. GSK3179106 is a RET kinase inhibitor that was administered in double-blind, randomized, placebo-controlled single-dose and repeat-dose studies in healthy subjects to investigate its pharmacokinetics and safety/tolerability. In the single-dose study (n = 16), GSK3179106 was dosed from 10 mg to 800 mg, ...
Cancer care drug costs are rising due to a variety of factors, and safety concerns account for some of the cost. At the same time, clinical and economic concerns drive drug safety improvements. This chapter examines pressures on drug costs due to the complexity of care and drug therapies, marked structure in which care is provided, and regulatory requirements driving safety.
We have synthesized a sustained-release lidocaine sheet (SRLS) using biodegradable polymers and previously demonstrated its safety and long-term analgesic effect in the normal mucous membrane of healthy human volunteers.
With increasing expectations to provide evidence of drug efficacy, safety, and cost-effectiveness, best-in-class drugs are a major value driver for the pharmaceutical industry. Superior safety is a key differentiation criterion that could be achieved through better risk:benefit profiles, safety margins, fewer contraindications, and improved patient compliance. To accomplish this, comparative safety assessments using innovative and adaptive nonclinical and clinical outcome-based approaches should be undertak...
In this open-label study (NCT02142920), we investigated the distribution, pharmacokinetics, and metabolism of the pan-class-I isoform phosphatidylinositol 3-kinase/mammalian target of rapamycin inhibitor gedatolisib (PF-05212384), following a single intravenous administration in healthy male subjects. A single, 89-mg, intravenous dose of gedatolisib was associated with a favorable safety profile in the 6 healthy subjects evaluated. Peak plasma concentrations for unchanged gedatolisib and total radioactivity...
The paucity of safety information on intrauterine devices (IUD) for magnetic resonance imaging (MRI) examinations is clinically relevant. The aim of this study is to evaluate the MRI safety of clinically used IUDs composed of copper/gold and stainless steel at 1.5T and 3.0T.
NYX-2925, a new chemical entity, acts as a co-agonist to glutamate at the N-methyl-D-aspartate receptor (NMDAR). At low concentrations of endogenous agonists (glycine/D-serine), NYX-2925 partially activates NMDARs, modulating neural pathways relevant for chronic pain. NYX-2925 is being developed for the treatment of chronic pain conditions, including painful diabetic peripheral neuropathy and fibromyalgia. In this first-in-human, Phase 1, single- (50-1200 mg) and multiple-ascending dose (150-900 mg) study, ...
Korean Red Ginseng (KRG) has been used in Asia for its various biological effects, but no studies have investigated the safety of its long-term intake. Therefore, the present study evaluated the safety of KRG intake for 24 weeks.
This study establishes the correlations between performance of a set of key safety factors and the actual lagging performance of oil platforms in Malaysia, hence the relevance of the key safety factors in evaluating and predicting the safety performance of oil and gas platforms. The key factors are crucial components of a safety performance evaluation framework and each key safety factor corresponds to a list of underlying safety indicators.
Evaluating organizational safety culture is critical for high-stress, high-risk professions such as prehospital emergency medical services (EMS). The aim of the study was to evaluate the psychometric properties of a safety culture instrument for EMS, based on the Agency for Healthcare Research and Quality's widely used Surveys on Patient Safety Culture (SOPS).
ELX-02 is an investigational synthetic eukaryotic ribosome-selective glycoside optimized as a translational read-through molecule that induces read through of nonsense mutations, resulting in normally localized full-length functional proteins. ELX-02 is being developed as a therapy for genetic diseases caused by nonsense mutations. Two phase 1a, randomized, double-blind placebo-controlled, single-ascending-dose studies were conducted in healthy human subjects to evaluate the safety and pharmacokinetics of E...
The pharmacokinetics (PK) of β-lactam antibiotics in cystic fibrosis (CF) patients has been compared with that in healthy volunteers for over four decades; however, no quantitative models exist that explain the PK differences between CF patients and healthy volunteers in older and newer studies. Our aims were to critically evaluate these studies and explain the PK differences between CF patients and healthy volunteers. We reviewed all 16 studies that compared the PK of β-lactams between CF patients and h...
To evaluate the potential for ethnicity-related differences in ataluren pharmacokinetics (PK) and safety, a phase 1 single-dose study was conducted in 48 healthy (24 Japanese and 24 Caucasian subjects), nonsmoking male volunteers who were equally divided into 3 cohorts of oral doses at 5, 10, and 20 mg/kg. Blood samples were collected until 48 hours postdose. PK results demonstrated rapid absorption of ataluren, with peak plasma levels (C ) being attained between 0.875 and 2.5 hours after dosing. The mea...
Safety and tolerability of HIV-1 multiantigen pDNA vaccine given with IL-12 plasmid DNA via electroporation, boosted with a recombinant vesicular stomatitis virus HIV Gag vaccine in healthy volunteers in a randomized, controlled clinical trial.
The addition of plasmid cytokine adjuvants, electroporation, and live attenuated viral vectors may further optimize immune responses to DNA vaccines in heterologous prime-boost combinations. The objective of this study was to test the safety and tolerability of a novel prime-boost vaccine regimen incorporating these strategies with different doses of IL-12 plasmid DNA adjuvant.
Pharmacokinetics, Safety and Tolerability of Tylerdipine Hydrochloride, a Novel Dihydropyridine Dual L/T-type Calcium Channel Blocker, after Single and Multiple Oral Doses in Healthy Chinese Subjects.
Tylerdipine hydrochloride (KBP-5660) is a novel L/T-type dual calcium channel blocker developed for the treatment of hypertension. We aimed to study the pharmacokinetics, safety and tolerability of tylerdipine in healthy Chinese subjects.
Enormous progress has been made globally in the use of evidence derived from patients' clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world...
Current gaps in drug safety sciences can result from the inability i) to identify hazard across multiple target organs, ii) to predict and risk assess with certainty against drug safety liabilities for the major target organs iii) to optimally manage and mitigate against drug safety liabilities and iii) to apply principles of governance on the generation, integration and use of experimental data. Translational safety assessment to evaluate several target-organ drug toxicities can only be partially achieved ...
The professional identity of safety professionals is rife with unresolved contradictions and tensions. Are they advisor or instructor, native or independent, enforcer of rules or facilitator of front-line agency, and ultimately, a benefactor for safety or an organizational burden? Perhaps they believe that they are all of these. This study investigated professional identity through understanding what safety professionals believe about safety, their role within organizations, and their professional selves. U...
to evaluate the safety of a topical formulation containing chamomile microparticles coated with chitosan in the skin of healthy participants.
There is limited research on healthy volunteers' perceptions of the risks of Phase I clinical trials. In order to contribute empirically to long-standing ethical concerns about healthy volunteers' involvement in drug development, it is crucial to assess how these participants understand trial risks. The objectives of this study were to investigate (1) participants' views of the overall risks of Phase I trials, (2) their views of the risk of personally being harmed in a trial, and (3) how risk perceptions va...
1-Deoxynojirimycin (DNJ) is a potent α-glucosidase inhibitor and thus beneficial for prevention of diabetes. While we have succeeded in obtaining the culture supernatant extract (CSE) rich in DNJ from microorganism source, information regarding its anti-hyperglycemic effect and safety were still limited. Therefore, this study was aimed to evaluate the anti-hyperglycemic effect and safety of microorganism DNJ. Oral sucrose tolerance test was performed, and the result showed that CSE was able to significantl...
Valid algorithms for identification of cardiovascular (CV) deaths allow researchers to reliably assess the CV safety of medications, which is of importance to regulatory science, patient safety, and public health.