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Systemic Bioavailability of Sublingual Atropine Ophthalmic Solution: a Phase I Study in Healthy Volunteers with Implications for Use as a Contingency Medical Countermeasure
IntroductionAtropine sulfate is an FDA-approved medical countermeasure (MCM) for the treatment of organophosphorus nerve agent and organophosphate...
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Lung function and self-rated symptoms in healthy volunteers after exposure to hydrotreated vegetable oil (HVO) exhaust with and without particles
BackgroundDiesel engine exhaust causes adverse health effects. Meanwhile, the impact of renewable diesel exhaust, such as hydrotreated vegetable oil...
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Predictive performance of parent-metabolite population pharmacokinetic models of (S)-ketamine in healthy volunteers
PurposeThe recent repurposing of ketamine as treatment for pain and depression has increased the need for accurate population pharmacokinetic (PK)...
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Residual effects of zopiclone on driving performance using a standardized driving simulator among healthy volunteers
RationaleThe effects of hypnotics on automobile driving have been attracting increasing attention. However, few driving simulators (DSs) have been...
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Results From Phase I Studies Investigating the Dose Linearity of Finerenone Tablets and the Influence of Food or pH-Modifying Comedications on its Pharmacokinetics in Healthy Male Volunteers
Background and ObjectivesFinerenone is a nonsteroidal mineralocorticoid receptor antagonist that reduces the risk of adverse kidney and...
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Safety, Tolerability, and Pharmacokinetic Study of 101BHG-D01 Nasal Spray, a Novel Long-Acting and Selective Cholinergic M Receptor Antagonist, in Healthy Chinese Volunteers: A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation, First-In-Human Study
Background and Objective101BHG-D01 nasal spray is the first novel long-acting cholinergic M receptor antagonist under development to treat rhinorrhea...
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Pharmacokinetic interaction between atorvastatin and fixed-dose combination of sofosbuvir/ledipasvir in healthy male Egyptian volunteers
PurposeComorbid conditions of heart and liver disorders added to HCV-induced hepatic steatosis make co-administration of statins, and direct-acting...
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Cerebral arterial flow dynamics during systole and diastole phases in young and older healthy adults
BackgroundSince arterial flow is the leading actor in neuro-fluids flow dynamics, it might be interesting to assess whether it is meaningful to study...
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Population Pharmacokinetic Modelling of Acetaminophen and Ibuprofen: the Influence of Body Composition, Formulation and Feeding in Healthy Adult Volunteers
Background and ObjectiveCombined acetaminophen and ibuprofen are common antipyretic and analgesic drugs. Formulation and feeding affect drug...
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Fixed Dose Combination Tablets of Aripiprazole and Divalproex Sodium: a Pilot Pharmacokinetic Study in Human Volunteers
A combination product of aripiprazole (antipsychotic) and divalproex sodium (mood stabilizer) was recently developed to establish their tolerability...
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Sequence variation of the Epstein-Barr virus nuclear antigen 1 (EBNA1) gene in chronic lymphocytic leukemia and healthy volunteer subjects
Epstein-Barr virus–related malignancies have been linked to variations in the sequences of EBV genes, notably EBNA1. Therefore, the purpose of this...
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Influence of a Passive Tilt Test on the Proteomic Composition of the Blood of Healthy Humans
In order to identify changes in the blood proteome of healthy volunteers after passive tilt test carried out on day 19 of head-down bed rest, a...
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The motivations, barriers, and sociodemographic characteristics of healthy Chinese volunteers in phase I research
PurposeTo describe the motivations, barriers, and sociodemographic characteristics of healthy Chinese volunteers in phase I research and to...
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Population pharmacokinetic/pharmacodynamic modeling of nifekalant injection with varies dosing plan in Chinese volunteers: a randomized, blind, placebo-controlled study
Nifekalant hydrochloride is a class III antiarrhythmic agent which could increase the duration of the action potential and the effective refractory...
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Three-Dimensional Feature Tracking Study of Healthy Chinese Ventricle by Cardiac Magnetic Resonance
PurposeMyocardial strain, as a crucial quantitative indicator of myocardial deformation, can detect the changes of cardiac function earlier than...
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Population Pharmacokinetics of Vixotrigine in Healthy Volunteers and Subjects with Trigeminal Neuralgia, Painful Lumbosacral Radiculopathy and Erythromelalgia
BackgroundVixotrigine is a voltage and use dependent sodium channel blocker currently under development for treatment of various neuropathic pain...
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Assessment of the impact of mitochondrial genotype upon drug-induced mitochondrial dysfunction in platelets derived from healthy volunteers
Mitochondrial DNA (mtDNA) is highly polymorphic and encodes 13 proteins which are critical to the production of ATP via oxidative phosphorylation. As...
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The effect of potent CYP2D6 inhibition on the pharmacokinetics and safety of deutetrabenazine in healthy volunteers
PurposeDeutetrabenazine is a deuterated form of tetrabenazine with a confirmed lower rate of CYP2D6 metabolism of the active metabolites, α- and...
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Acute cardiovascular effects of controlled exposure to dilute Petrodiesel and biodiesel exhaust in healthy volunteers: a crossover study
BackgroundAir pollution derived from combustion is associated with considerable cardiorespiratory morbidity and mortality in addition to...