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Safety clinical trials

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NCT ID: NCT06345950 Completed - Safety Clinical Trials

Pharmacokinetics and Safety of a New Micellar Glutathione Formulation

Start date: June 21, 2022
Phase: N/A
Study type: Interventional

This study seeks to determine the short-term effects of daily oral supplementation with a new micellar Glutathione formulation (LipoMicel) on the oral absorption and safety of glutathione in healthy volunteers. The primary objective of this study is to evaluate and compare the pharmacokinetics of a novel micellar Glutathione (GSH) formulation with that of a standard formulation as well as a liposomal GSH formulation. The secondary objective is to evaluate the safety of a new micellar GSH formulation with higher bioavailability in human participants over a 30-day study period.

NCT ID: NCT06072170 Completed - Pharmacokinetics Clinical Trials

Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience

Start date: September 12, 2023
Phase: Phase 1
Study type: Interventional

Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal. Due to limited data availability, the goal of this clinical trial is to learn about safety, pharmacokinetics (what the body does to the drug) and pharmacodynamics (what the drug does to the body) of Kratom in adult recreational polydrug users with opioid experience.

NCT ID: NCT05970887 Completed - Safety Clinical Trials

Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines

Start date: October 12, 2022
Phase: Phase 4
Study type: Interventional

The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthy adults during 2022-23 season.

NCT ID: NCT05910918 Completed - Safety Clinical Trials

Intensive Care Nurses' Training Package on the Safety Culture of Geriatric Patients

Start date: November 30, 2022
Phase: N/A
Study type: Interventional

This study aims to determine the effect of intensive care nurses' training package on the safety culture of critically ill geriatric patients. Study hypothesis: Intensive care nurses who receive the proposed training package exhibit higher scores on critically ill geriatric patients' safety culture awareness than those who do not receive it.

NCT ID: NCT05847218 Completed - Pharmacokinetics Clinical Trials

Phase 1 Clinical Trial of RHN-001 in Healthy Adult Volunteers

Start date: March 9, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical Trial is to assess the safety, tolerability and Pharmacokinetic profile of 750 mg single oral dose of RHN-001 and 1500 mg of RHN-001 administered orally in fasted and fed conditions in healthy adult volunteers.

NCT ID: NCT05698095 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers

Start date: December 27, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.

NCT ID: NCT05627518 Completed - Pharmacokinetics Clinical Trials

Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation

BA
Start date: November 15, 2022
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.

NCT ID: NCT05592951 Completed - Safety Clinical Trials

Safety and Tolerability of a Novel Amino-acid Based Hydration Drink in Healthy Volunteers

Start date: September 30, 2022
Phase: N/A
Study type: Interventional

The nutrient composition of this product is similar to the existing Liquid IV "hydration multiplier" product already on the market but with the addition of amino acids. With such low quantities of amino acids, in particular as compared to the amounts consumed in normal diets, there is no reason to believe that the product would cause any adverse outcomes. However, since no research has been done on the safety of regular consumption of this product, this study will evaluate the safety of the product with regards to routing blood chemistries and other variables. Specifically, standard testing will be performed including a measurement of vital signs, comprehensive metabolic panel, hematology panel, urinalysis, and quantification of triiodothyronine, thyroxine, and thyroid stimulating hormone. A questionnaire will also be used to assess product tolerability.

NCT ID: NCT05451355 Completed - Safety Clinical Trials

Developing a Dyadic Shared Decision Making Tool About Firearm Storage

Start date: July 15, 2022
Phase: N/A
Study type: Interventional

Given that firearm ownership is legal, common, and valued by many people in the U.S, safe storage is important to minimize the risk of unauthorized access, injury and death. Safe storage is particularly important in households with children, as they are at elevated risk of death by unintentional injury or suicide if a gun is accessible in the home. However, only 1/3 of firearm-owning parents with children in the home report consistently safe storage. Decisions about firearm storage are complex, with perceived costs and benefits of different storage options varying by individual factors (i.e., primary reasons for firearm ownership, types of firearms), family factors (i.e., age and mental and physical health of household members), and community factors (i.e., crime and norms). Storage decisions affect all household members, and prior research finds that firearm owners who discuss storage with other family members have the safest storage practices. However, a recent survey study of firearm-owning US parents of school-aged youth (n=749) found that in only 55% of parenting dyads are both parties highly involved in the decision about how firearms are stored. In this sample, investigators observed that safe storage was more likely when both members of a parenting dyad were highly involved in the storage decision (regardless of their gender and whether one or both own firearms). However, at present firearm storage interventions are directed at individuals rather than family systems. Given the prevalence of pediatric firearm injuries and the role of within-family processes in storage safety, there is a critical need to develop a feasible, self-directed, family-centered firearm safety intervention. The objective of the proposed short-term project is to develop and obtain preliminary data about acceptability and feasibility of a prototype of a brief decision aid for parenting dyads. The conceptual framework for the decision aid is the Ottawa Decision Support Framework, and then investigators will adapt the Ottawa Person Decision Guide for Two to this issue and for self-facilitation outside of the clinical setting.

NCT ID: NCT05353686 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Trial Investigating the Effect of 4 Weeks Dosing of XEN-D0501 on Blood Glucose Reduction in Patients With Diabetes

Start date: February 25, 2019
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, parallel-group trial investigating the effect of 4 weeks bi-daily dosing of XEN-D0501 on blood glucose reduction as add-on to metformin in patients with diabetes mellitus type 2 where life style changes and treatment with metformin has failed to effectively reduce blood glucose concentrations.