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Healthy Volunteers clinical trials

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NCT ID: NCT02393950 Completed - Clinical trials for Healthy Volunteer Study

Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers

FIMPAM
Start date: March 2015
Phase: Phase 1
Study type: Interventional

The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.

NCT ID: NCT02391181 Completed - Healthy Volunteers Clinical Trials

Bioequivalence Study With Pharmacokinetic Endpoints, Comparing a Single Dose of Iron Sucrose Azad Injection of Azad Pharma Corporation (AG), With a Single Dose of Venofer® Injection of Vifor Corporation (AG) in Healthy Adult Volunteers

Start date: November 2014
Phase: Phase 1
Study type: Interventional

A Clinical Trial to Demonstrate the Comparability of the Two Iron Sucrose Injection Solutions Iron Sucrose Azad of Azad Pharma AG and Venofer® of Vifor Pharma AG. The Hypothesis is That Both Iron Sucrose Injection Solutions Reveal the Same Active Substance Availability in the Blood Circuit.

NCT ID: NCT02390765 Recruiting - Obesity Clinical Trials

Children s Growth and Behavior Study

Start date: April 21, 2015
Phase:
Study type: Observational

Background: - Studies show that many factors affect children s eating behavior and health. These include sleep, mood, thinking skills, and genetics. Studying children over time may identify children at higher risk for eating-related health concerns. Objective: - To understand how genes and environment influence eating behavior and health over time. Eligibility: - Children ages 8 17 in good general health. Design: - Screening visit 1: Medical history, physical exam, body measurements, and questions. - 14 days: Participants will wear a wrist monitor and answer smartphone prompts about eating and mood. They may give a stool sample. - Screening visit 2: - Body measurements. - Saliva, urine, and blood samples. - Heart tests. - Meals provided (after fasting overnight). - Questionnaires and interview. - Behavior, thinking, and exercise tests. - X-ray of left wrist and full body.<TAB> - Some parents may have medical history, physical exam, and questions at screening visits. They may answer questions at the yearly visits. - Participants will have up to 6 yearly visits. They will give a urine sample and body measurements, and repeat the X-rays. They will have questions and behavior and thinking tasks. They may give stool samples. Visits will range from 3 to 8 hours. - Participants may choose to participate in other studies: - Stress and Hormones, 1 visit: While resting, participants will give saliva samples and have their heart monitored. Then they will do math. They will repeat the resting part, then do a computer task. - Brain Imaging, 2 visits: Twice, participants will perform tasks with a magnetic cone on their head then answer questions. Once, they will have an MRI, lying still in a scanner with a coil on their head. - Sleep, 2 visits: Participants will have food provided, answer questions and do tasks. Participants will be compensated for the time and inconvenience involved with completing study procedures.

NCT ID: NCT02390492 Completed - Healthy Volunteer Clinical Trials

A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This 2-period, open-label, nonrandomized study will be conducted to determine the absolute bioavailability as well as the absorption, metabolism, and excretion of ipatasertib and its metabolite(s). Healthy male participants will receive a single 200-mg oral dose of ipatasertib followed 1 hour later by an 80-mcg/800-nCi intravenous dose of [14C]-ipatasertib. After a 4-day observation period and 10-day washout, participants will receive a single 200-mg/100-mcCi oral dose of [14C]-ipatasertib with subsequent data collection for an additional 7 to 14 days until discharge criteria are met.

NCT ID: NCT02389881 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability, and Pharmacokinetics of Multiple-Dose TAK-058 in Healthy Participants

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of TAK-058 in healthy non-elderly and elderly participants.

NCT ID: NCT02382640 Completed - Healthy Volunteers Clinical Trials

Effect of Antacid on Bioavailability of Febuxostat After Administration of a Febuxostat 80 mg Extended-Release Capsule

Start date: March 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the effect of antacid administration, and its timing, on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg.

NCT ID: NCT02382393 Completed - Healthy Volunteers Clinical Trials

Reliability and Validity of Online Cognitive Assessments

Start date: March 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the concurrent validity (correlation coefficient of scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a validated third party computerized assessment.

NCT ID: NCT02379429 Recruiting - Healthy Volunteers Clinical Trials

Care of the Urothelial Cancer Patient and Prospective Procurement of Urothelial Cancer Tissue

Start date: November 10, 2015
Phase:
Study type: Observational

Background: Urothelial cancer is cancer of the bladder, ureter, and urethra. Researchers want to better understand what changes in a person s cells and genes cause this cancer to form. This may help them find new ways to treat it. Objective: - To perform DNA sequencing to help researchers learn the differences between normal tissue and tumor tissue. Also, to learn how molecular changes - including gene changes - might help predict the course of disease and how people respond to therapy. Eligibility: - Adults age 18 and older who have or are suspected of having urothelial cancer or an inherited disorder that raises their risk of getting bladder cancer. Design: - Participants will be screened with a physical exam. Their medical records and tissue samples will be reviewed. - Eligible participants will give tissue blocks of their original tumor. The blocks will be put in a tissue bank. - Participants medical records may be reviewed. - Participants may have a medical history and physical exam. - Participants may have blood and urine tests. They may have imaging scans. They may give urine, blood, and saliva samples. These samples may be used in future research. - If participants need surgery for their cancer, researchers will keep some of the tissue (both tumor and normal tissue). The tissue may be used in future research. - Participants will go back to the Clinical Center in 6 months. They may give saliva, urine, and blood samples. After 6 months, they will be seen by their local doctor for standard post-surgical visits. - Participants will be called every 6 months to give health updates.

NCT ID: NCT02374437 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol and Food Effect in Healthy Volunteers

Start date: April 2014
Phase: Phase 1
Study type: Interventional

This is a single-site, randomized, partly double-blind, placebo-controlled study of Aramchol in sixty six (66) healthy male volunteers. In each part of the study subjects will be enrolled in the study within 28 days before drug administration(s). The study will consist of three parts and the subjects will be assigned to three Parts.

NCT ID: NCT02373891 Completed - Healthy Volunteers Clinical Trials

Study to Evaluate the Effect of Food on the Pharmacokinetics of Surfolase CR Tablet in Healthy Volunteers

Start date: April 2014
Phase: Phase 1
Study type: Interventional

Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally administered as a salt composed of an acid-base as a compound that was synthesized by and chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state is allowed to recuperate or extended. It was developed to improve compliance improve pharmaceutically Acebrophylline that intake twice daily 100mg to Surfolase CR that intake once daily 200mg