View clinical trials related to Healthy Volunteers.
Filter by:A randomized, double-blind, placebo-controlled, single ascending dose study of AR882 in healthy adult males.
Background: The COVID-19 outbreak has caused many changes to people s normal social patterns. The respiratory illness has been the major focus of public health efforts. But most experts also agree that government and public health mandates to slow the spread of the illness, such as social distancing, have a significant effect on people s mental health. Environmental stressors, such as constraints on activities, social contact, and access to resources, take a toll. Researchers want to learn how stressors related to COVID-19 affect mental health over time. Objective: To learn the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of people. Eligibility: English-speaking adults ages 18 and older Design: This study will be conducted online. Participants will give their first and last name and email address. They will indicate if they have ever been in an NIH research study. They will get a username and password. Every 2 weeks for up to 6 months, participants will complete online study surveys. They will get email reminders. Some surveys will be repeated. At the end of the study, they will complete a set of end-of-study surveys. The surveys will ask about the following: Age, sex, race, and other sociodemographic data Mental and medical illness history and treatment Family medical history Mobility, self-care, and life activities Behaviors related to alcohol and substance use disorder Mental illness symptoms Psychological distress Stressors caused by the COVID-19 pandemic. Participants will get links to mental health resources, such as hotlines. They will also get guidance on steps to take to seek care or support. Study website: nimhcovidstudy.ctss.nih.gov
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of fluzoparib in healthy Caucasian and Chinese subjects
A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Non-invasive sensors have been used in research in the United States (US) to aid in the assessment of a subject's heart rate (HR), respiratory rate (RR) and fluid volume status. This estimate and its trended value over time, when used along with clinical signs and symptoms and other subject test results, can aid in the process of reaching a diagnosis and formulating a therapeutic plan when abnormalities of volume status, or RR are suspected. Non-invasive sensors like the Peripheral IntraVenous Analysis (PIVA) sensor under development by Baxter and the Deltran blood pressure (BP) transducer, capture waveforms created by physiological mechanisms such as blood flow and breathing. An algorithm is then applied to the captured waveform to give clinicians an idea of hemodynamic (volume) status, and RR. In this study, the functional robustness (e.g., subjects sitting, elevated leg positions, etc.) of the PIVA algorithm/technology will be demonstrated by evaluating the impact of various common interventions on the venous pressure signal. All subjects will undergo 33 interventions expected to take approximately 4 - 6 hours.
The pharmacokinetics, safety, and tolerability of meloxicam eye drops in Chinese healthy volunteers were evaluated to provide a basis for the formulation of a phase II clinical trial dosing regimen for this product. Including pre-tests and formal trials, formal trials include single-dose pharmacokinetics tests and multiple-dose tolerance tests (4 times a day for 3 consecutive days).
Background: Tetrahydrocannabinol (THC) is a partial CB1/CB2 agonist and causes its pharmacological effects by binding to cannabinoid receptors. CB1 receptors are predominantly located in the brain (highest densities at hippocampus, cerebellum and the striatum) and at low levels in the brainstem. CB2 receptors are predominantly in the spleen and in hematopoietic cells. THC is highly lipophilic and is readily absorbed and distributed to the brain and other organs. Most of the neuropsychological studies carried out so far show that the mainly affected neurocognitive functions in cannabis users are: memory, attention, psychomotor capacity, speed of information processing and alterations of executive functions (resistance to interference, planning capacity, decision-making, verbal fluency and working memory). These effects are dose-dependent. Hypothesis: Functional CB1 receptor activation by the THC contained in the cannabis flos will induce dose-dependent effects on EEG, physiological functions and behavior: 1. EEG alterations. 2. Increase in cannabis subjective effects. 3. Increase in heart rate. 4. Increase in psychopathology scale Psychotomimetic State Inventory (PSI) score. 5. Increase in plasma cortisol concentrations. Objectives: Main pharmacodynamic objective: To assess the effects of Cannabis flos on electroencephalography (EEG) in healthy recreational cannabis users. Secondary pharmacodynamic objectives: (i) To assess the effects of Cannabis flos on: cannabis subjective effects, heart rate and psychopathology scale; (ii) To establish the pharmacokinetic/pharmacodynamic relationships between THC plasma concentrations and pharmacodynamic endpoints. Safety and tolerability objectives: To assess the safety and tolerability of THC in these subjects. Methods: Phase I, prospective, monocentric, double-blind, randomized, placebo-controlled, parallel group study to assess the THC effects on EEG neural oscillations in 16 healthy subjects with recreational cannabis use.
A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP1906 Tab. 5 mg and YHR1902 Tab. 5mg in healthy volunteers
A study to assess multiple ascending doses of AR882 in healthy adult males.
No actual human data for pharmacokinetics, metabolism, safety, pharmacodynamics, nor efficacy parameters are available for inhaled medical cannabis. This study was designed to investigate the innocuity and tolerability levels as well as the pharmacokinetic profile of this combination when smoked/inhaled as intended in clinical therapeutic use (i.e. patients with neuropathic pain). Consecutive dosing (over a period of 7 days) should allow to test the tolerability of chronic administration. In addition, the impact of the THC/cannabidiol pharmacological activity on the cognition activity, cognitive test will be performed before and throughout the treatment and compared to the plasma levels of THC/cannabidiol following single and multiple dosing.