Journal of Pharmacogenomics & Pharmacoproteomics

Kramskay R

Publications

• Research Article
  Pharmacokinetics and Safety of Sublingual Flumazenil (CRLS035) in Healthy Adults (Potential Therapy for Hepatic Encephalopathy)
  Author(s): Saadi T, Kramskay R, Zilberman Peled B, Katz N, Peled N and Baruch YSaadi T, Kramskay R, Zilberman Peled B, Katz N, Peled N and Baruch Y
  
  Flumazenil, a GABAA receptor antagonist, has a significant clinical benefit especially in overt hepatic encephalopathy patients, although it requires intravenous access. A novel highly concentrated sublingual spray formulation of flumazenil (CRLS035) was developed by Coeruleus Ltd. The aim of this study was to determine the single dose safety and pharmacokinetics of sublingual CRLS035 versus flumazenil intravenously (IV) in healthy volunteers. Ten healthy adult volunteers participated in the study. CRLS035 was administered sublingually in two doses (1.1 mg and 2.2 mg) vs. IV flumazenil (0.2 mg). Subjects were evaluated after a high-fat diet and water consumption. Blood samples were collected pre- and post-dose at eight time points. Flumazenil levels were analyzed for Cmax, Tmax, Cmin, Tmin, AUC0-∞, AUC0-t and T1/2. Safety variables included local oral area and assessment.. View More»
  DOI: 10.4172/2153-0645.1000140

  Abstract PDF