XC8 Safety, Tolerability and Pharmacokinetics in Healthy Volunteers

Exclusion Criteria

• •1. Hepatic disorder or renal disease; any other disease that, in the opinion investigator, may affect the results of the study, or may lead to the health aggravation during the study;
• •2. Laboratory abnormalities at screening;
• •3. Course intake of medicinal products (including herbs and biologically active additives) for preventive or curative purposes within 1 month prior to screening;
• •4. Antibodies to HIV and hepatitis C virus, the presence of the hepatitis B surface antigen, a positive syphilis test;
• •5. The presence of a sleep disorder (for example, night work, sleep disturbances, insomnia, recent return from another time zone, etc.);
• •6. Signs of alcohol or drug abuse; taking alcohol or drugs during 4 days before screening;
• •7. History of allergies (including medicines and food products);
• •8. Symptomatic rhinitis in anamnesis during 2 years prior to screening (allergic rhinitis, non-allergic rhinitis or pollinosis);
• •9. Blood donation / plasma, surgical intervention (in a hospital environment) during 12 weeks before screening;
• •10. Participation in other clinical trials or taking the study drug during 3 months before screening;
• •11. Impossibility to understand or follow protocol instructions;
• •12. Smoking 3 months before screening;
• •13. Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• •14. Acute infectious diseases less than 4 weeks before the start of the study.