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Healthy Subjects clinical trials

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NCT ID: NCT04027803 Completed - Healthy Subjects Clinical Trials

Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris®

Start date: September 21, 2018
Phase: Phase 1
Study type: Interventional

A Double-blind, Randomized Clinical Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 (JSC BIOCAD, Russia) and Soliris® in Healthy Volunteers

NCT ID: NCT03989518 Completed - Healthy Subjects Clinical Trials

The Link Between Mental Imagery and the Reduction of Fear in Imaginal Extinction

Start date: February 25, 2019
Phase: N/A
Study type: Interventional

Imaginal exposure is a widely used psychological treatment technique. Imaginal extinction is an experimental analogue of imaginal exposure, that allows the study of this treatment technique under controlled circumstances (Agren, Björkstrand, & Fredrikson, 2017). During imaginal extinction, experimentally induced fear is diminished through repeated exposure to mental imagery of the feared (conditioned) stimulus. However, it is not known to what extent fear reduction depends on the mental imagery produced during this procedure. A better understanding of the mechanisms driving the effects of imaginal exposure and the factors moderating fear reduction could have significant clinical utility, by suggesting mechanistically informed ways to improve this treatment.

NCT ID: NCT03980080 Completed - Healthy Subjects Clinical Trials

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects

Start date: December 19, 2018
Phase: Phase 1
Study type: Interventional

This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects.

NCT ID: NCT03968848 Completed - Healthy Subjects Clinical Trials

Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite

Start date: November 12, 2018
Phase: Phase 1
Study type: Interventional

This study is investigate the influence of severe hepatic impairment on the pharmacokinetics of acalabrutinib and its metabolite.

NCT ID: NCT03943745 Recruiting - Healthy Subjects Clinical Trials

EEG Changes During Induction of Propofol Anesthesia

PropoStatus
Start date: October 25, 2018
Phase:
Study type: Observational

PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol.

NCT ID: NCT03942458 Completed - Healthy Subjects Clinical Trials

Pharmacokinetics and Pharmacodynamics of Vicagrel in Healthy Adult Subjects of Different CYP2C19

Start date: April 3, 2019
Phase: Phase 1
Study type: Interventional

This study is a single-center, randomized, open, two-cycle crossover, clopidogrel control, multiple dosing study. The aim was to evaluate the pharmacokinetic/pharmacodynamic behavior of different metabolites of CYP2C19 in healthy subjects. The study enrolled 48 patients, divided into three groups of CYP2C19 fast metabolite, middle metabolite, and slow metabolism, 16 cases in each group. All groups of subjects were administered for 7 days in the first cycle, once a day (loading dose on the first day, maintenance dose on other days), and entering the 14-day washout period after the end of the first cycle. The second cycle was entered, and the second cycle was administered for 7 days, once a day (the first day was given a loading dose, and the other days were given a maintenance dose). Blood was collected before and after administration of D1, D7, D22, and D28, and PK/PD was measured.

NCT ID: NCT03936907 Completed - Healthy Subjects Clinical Trials

Comparison of Safety, Tolerability and Pharmacokinetics of Medical Grade Cannabis (MGC) Orally Disintegrating Tablets With Buccal Sativex®, in Healthy Adult Volunteers

Start date: April 15, 2019
Phase: Phase 1
Study type: Interventional

This is a preliminary study designed to assess the safety and properties of a new oral formulation containing the two most common cannabinoids used for medicinal purposes - Tetrahydrocannabinol (THC) and Cannabidiol (CBD). The formulation is designed to disintegrate sublingually in order to enhance absorption of these ingredients by circumventing first-pass metabolism by the liver (and probably also by the intestinal mucosal cells) as well as gastric acid degradation, thus allowing a rapid onset and more intensive pharmacological effect.

NCT ID: NCT03928262 Completed - Healthy Subjects Clinical Trials

Pharmacokinetic Study of Benralizumab in Healthy Chinese Subjects

Start date: April 2, 2019
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, single-blind study in healthy Chinese subjects at single dose administration of benralizumab: Treatment 1, Treatment 2 and Treatment 3. The study design allows an assessment of 3 doses with safety monitoring and PK sampling to evaluate the safety, tolerability and PK profile of benralizumab.

NCT ID: NCT03918330 Active, not recruiting - Healthy Subjects Clinical Trials

Spatial Analysis of the Intestinal Microbiota in Healthy Subjects

Start date: August 1, 2018
Phase:
Study type: Observational

Research on the human intestinal microbiota is common as there is rising evidence of its influence on host physiology and several diseases. Predominantly, it has been based on analyses of faecal samples because of their easy sampling. A minority of studies investigated the gut microbiota using mucosal samples. Not much is known about the spatial differences in microbiota composition along the large bowel. The spatial differences of the gut microbiota without preparation of the bowel have not been analysed yet. Furthermore, the composition of the microbiota of the luminal gut content has not been analysed yet. This study aims to gain knowledge of the microbial composition of luminal and mucosal samples at different segments of the lower gastrointestinal tract: ileum, caecum, ascending colon, transverse colon, descending colon, sigmoid colon and rectum, as well as of rectal swabs and faecal samples.

NCT ID: NCT03918213 Recruiting - Healthy Subjects Clinical Trials

Normative Metrics of High-Resolution Anorectal Manometry With the Use of Solid-State Catheter in a Healthy Russian Cohort

Start date: April 25, 2019
Phase: N/A
Study type: Interventional

High resolution anorectal manometry (HRAM) normative values are still need to be studied in different populations and with the use of different (solid-state and water-perfused) systems. No studies on HRAM normative values in a Russian population without signs of functional and organic anorectal pathology has been carried out yet.