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Healthy Volunteers clinical trials

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NCT ID: NCT02927353 Completed - Healthy Volunteer Clinical Trials

A Phase 1 Pharmacokinetic Bioequivalence Study of DMB-3113 and Adalimumab in Healthy Japanese Adult Male Subjects

DMB-3113-1
Start date: August 2016
Phase: Phase 1
Study type: Interventional

To determine the pharmacokinetic bioequivalence of DMB-3113 and adalimumab and to confirm the safety of the study drug in healthy Japanese adult male subjects

NCT ID: NCT02923791 Completed - Healthy Volunteers Clinical Trials

A Study in Healthy Volunteers to Assess Immune Response to Multiple Injections of Filgrastim Hospira or Neupogen Reference Product.

Start date: October 2016
Phase: Phase 1
Study type: Interventional

This study compares the potential immunogenicity of two filgrastims, the proposed biosimilar Filgrastim Hospira (US) and the US-approved Neupogen reference product. Subjects will receive doses of one of the two filgrastims by injection of 5 micrograms/kilogram (mcg/kg). Subjects will receive 5 consecutive daily doses in Period 1 (Days 1-5) and a single dose on Day 1 of Period 2. Pre-dose and serial post-dose assessments of immunogenicity will be conducted each of the two study periods. In addition, safety assessments will be conducted throughout the study.

NCT ID: NCT02923583 Completed - Healthy Volunteers Clinical Trials

Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects

Start date: October 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is assess the pharmacokinetics and safety of M834 and Orencia ® following administration of a single-dose in healthy volunteers.

NCT ID: NCT02923102 Completed - Healthy Volunteers Clinical Trials

Effects of Recoverben® on Recovery After Exhaustive Exercise

Start date: October 2016
Phase: N/A
Study type: Interventional

The aim of the study is to investigate a pre and post workout supplementation (15 days) with Recoverben® , a Aloysia citriodora extract on recovery after exhaustive exercise. Effects will be investigated with 400mg Recoverben® and compared to placebo.

NCT ID: NCT02922946 Completed - Healthy Volunteers Clinical Trials

Study to Determine the Effect of the Timing of a Meal on the Pharmacokinetics of Entinostat

Start date: October 11, 2016
Phase: Phase 1
Study type: Interventional

The objectives of this study are to evaluate the effect of the timing of a moderate-fat meal on the single dose pharmacokinetics of entinostat and to evaluate the safety and tolerability of entinostat under fed and fasting conditions in healthy adult subjects.

NCT ID: NCT02922933 Completed - Healthy Volunteers Clinical Trials

A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in Healthy Adult Subjects

Start date: October 25, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is therefore to evaluate the effect of concomitant drugs through an increase of intra-gastric pH levels on the bioavailability of entinostat. The primary objectives of this study are to evaluate the effect of multiple doses of omeprazole, famotidine, and the effect of an acidic beverage in combination with omeprazole on the single-dose PK profile of entinostat. The secondary objectives are to evaluate the safety and tolerability of a single dose of entinostat when administered with multiple doses of omeprazole, famotidine, and when administered with an acidic beverage in combination with omeprazole.

NCT ID: NCT02922426 Completed - Healthy Volunteers Clinical Trials

An Insulin Sensitivity Study in Healthy Subjects

Start date: September 2016
Phase: Phase 1
Study type: Interventional

This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.

NCT ID: NCT02916901 Completed - Healthy Volunteers Clinical Trials

Study to Investigate the Influence of CKD-519 on 24-h Ambulatory Blood Pressure in Healthy Adult Volunteers

Start date: August 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.

NCT ID: NCT02912377 Completed - Healthy Volunteers Clinical Trials

Immunogenicity and Pharmacodynamic of B12019 and Neulasta® in Healthy Subjects

Start date: September 2016
Phase: Phase 1
Study type: Interventional

Multiple-doses, randomised, double-blind, three-periods, two-sequences crossover study to assess the immunogenicity and pharmacodynamic comparability of a biosimilar pegfilgrastim (B12019) and the reference product Neulasta® in healthy subjects

NCT ID: NCT02910973 Completed - Healthy Volunteers Clinical Trials

Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway

TEACAP
Start date: September 2016
Phase: N/A
Study type: Interventional

Persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease the inflammatory cytokine response in healthy individuals.