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Safety Study of RP-1127 (Glyburide for Injection) in Healthy Volunteers

2014-08-27 03:13:21 | BioPortfolio

Summary

The primary objective of this study is to evaluate the safety and tolerability of RP-1127 (glyburide for injection), administered as a bolus dose followed by a 3 day continuous infusion. The secondary objectives are to assess the pharmacokinetics of RP-1127 and blood glucose and serum insulin PD responses to RP-1127.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Traumatic Brain Injury

Intervention

RP-1127 (Glyburide for injection), Placebo (RP-1127 excipients, excluding active)

Location

Jasper Clinic
Kalamazoo
Michigan
United States
49007

Status

Completed

Source

Remedy Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:21-0400

Clinical Trials [1615 Associated Clinical Trials listed on BioPortfolio]

Glyburide (RP-1127) for Traumatic Brain Injury (TBI)

This is a randomized, double-blind, placebo-controlled, multi-institutional study of IV RP-1127 (Glyburide for Injection) begun within 10 hours of complicated mild, moderate or severe trau...

Glyburide Opportunity for Spinal Cord Injury Protection

The purpose of this study is to determine the safety of using intravenous Glyburide (RP-1127) in patients with acute traumatic cervical spinal cord injuries (SCI).

Pilot Study of SBRT and CDX-1127 in Prostate Cancer

This study evaluates the combination of stereotactic body radiation therapy (SBRT) and CDX-1127 in subjects with castration resistant prostate cancer. Subjects will be randomized to one o...

Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma

This study evaluates whether it is safe to administer a peptide vaccine (6MHP) with adjuvants and the CDX-1127 monoclonal antibody, and whether the adjuvants and the CDX-1127 monoclonal an...

Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK)

The purpose of this study is to investigate if the drugs rifampin and fluconazole when given together increase the concentrations in the body of the oral diabetes medication glyburide.

PubMed Articles [8075 Associated PubMed Articles listed on BioPortfolio]

Novel excipients - regulatory challenges and perspectives - the EU insight.

Novel excipients are indispensable in development of modern, advanced drug delivery systems and biotechnology-derived drugs. Although numerous novel excipients are developed for pharmaceutical use, th...

Excipients in Parenteral Formulations: Selection Considerations and Effective Utilization with Small Molecules and Biologics.

Excipients form a major component of pharmaceutical formulations and are classified as any ingredient other than the active ingredient which is included within the product formulation to improve drug ...

A Novel Strategy to Identify Placebo Responders: Prediction Index of Clinical and Biological Markers in the EMBARC Trial.

One in three clinical trial patients with major depressive disorder report symptomatic improvement with placebo. Strategies to mitigate the effect of placebo responses have focused on modifying study ...

Biopharmaceutical evaluation of surface active ophthalmic excipients using in vitro and ex vivo corneal models.

The objective of this study was to systematically investigate the effects of surface active ophthalmic excipients on the corneal permeation of ophthalmic drugs using in vitro (HCE-T cell-based model) ...

Answer to the Letter to the Editor of Miao Yu et al. concerning "Is L5-S1 motion segment different from the rest? A radiographic kinematic assessment of 72 patients with chronic low back pain" by AB Sabnis et al. (Eur. Spine J; 27(5):1127-1135).

Medical and Biotech [MESH] Definitions

Intradermal injection of a heated (pasteurized) saline suspension of sarcoid tissue obtained from a sarcoid spleen or lymph node. In patients with active sarcoidosis a dusky red nodule develops slowly over the next few weeks at the injection site. Histologic examination, an essential part of the complete test, reveals sarcoid tissue.

An antidiabetic sulfonylurea derivative with actions similar to those of chlorpropamide.

Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Components of the cytoplasm excluding the CYTOSOL.

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