Study to Assess Pharmacokinetics, Safety, and Tolerability of XC-8

Exclusion Criteria

• •1. Hepatic or renal disease; any other disease, which may influence the clinical trial results or may lead to health worsening during the trial (according to the investigator's opinion);
• •2. Clinically significant laboratory abnormalities;
• •3. Use of any medication, including prophylaxis, within 1 month before screening (including herbal preparations and nutritional supplements);
• •4. Positive test for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus HBV at Screening;
• •5. Irregular sleep (e.g. night work, sleep disturbances, insomnia, returning from another time zone, etc.);
• •6. History or current evidence of alcohol or drug abuse; alcohol or drug intake within 4 days before Screening;
• •7. History or current evidence of allergic reactions (including reactions to medications and food);
• •8. History or current evidence of symptomatic rhinitis within 2 years before Screening (allergic rhinitis, non-allergic rhinitis, or hay fever, excluding short-term viral infection - cold or influenza);
• •9. Blood or plasma donation, or surgery (in hospital) within 12 weeks of Screening;
• •10. Lactating or pregnant females; a positive pregnancy test before the first administration of investigational medicinal product or breastfeeding;
• •11. Current or previous (within 3 months of enrollment) treatment with another investigational drug and/or medical device or participation in another clinical study;
• •12. Previous enrollment in this clinical study;
• •13. Inability to understand or follow protocol instructions;
• •14. Smoking within 3 months before screening or throughout the study;
• •15. Lactose intolerance;
• •16. History of allergic reactions to XC-8 or any inactive ingredients of the trial medication;
• •17. Employees of the sponsor or subjects who are employees or relatives of the investigator;