Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC Nizhpharm, Russia)

1. History of, or ongoing allergy/hypersensitivity to any of the study IMPs, or components thereof, or drug or any other allergy.

2. Known history or presence of malignant disease.

3. History or presence of angioedema, cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, neuromuscular, psychiatric, auto-immune, or neurological disorders; history or presence of cerebrovascular diseases (including cerebral circulation failure), or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.

4. Conditions associated with circulating blood volume decrease (including vomiting and diarrhea).

5. Any abnormalities in laboratory or instrumental test results which are outside the reference range of the Clinical investigational site.

6. Creatinine clearance \<80 mL/min based on the Cockcroft-Gault equation.

7. Systolic blood pressure \< 100 mmHg or \> 130 mmHg; diastolic blood pressure \< 70 mmHg or \> 90 mmHg; pulse \< 60 bpm or \> 90 bpm.

8. Medical history of surgery on gastrointestinal tract and hepatobiliary system (excluding appendectomy).

9. Adherence to special types of diets (such as vegetarian, vegan, with salt restriction within 30 days prior to the first administration of the IMP) and lifestyle (work at night, extreme physical activity).

10. Difficulty fasting or consuming standard meals.

11. No suitable veins for cannulation or repeated venepuncture.

12. Any other condition that is capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the IMP; or interfering with the interpretation of data, as judged by the Investigator.

13. Use of any prescribed or nonprescribed medication including herbal remedies, vitamins, and minerals within 14 days prior to the first administration of the IMP or longer if the medication has a long half-life.

14. Use of drugs interacting with the IMP (for detailed list of concerned drugs, see Section 8.3.4) within 30 days prior to the first administration of the IMP.

15. Females who:

* have used implanted, injected, intravaginal, or intrauterine hormonal contraceptives within 6 months prior to Screening;

* have used oral or transdermal hormonal contraceptives within 1 month prior to Screening.

16. Have had a tattoo or body piercing within 30 days prior to the first administration of the IMP.

17. Presence of Hepatitis B surface antigen (HbsAg) at Screening or a Positive Hepatitis C antibody test (Anti-HCV) result at Screening.

18. Positive human immunodeficiency virus (HIV) antibody test result at Screening.

19. Positive Rapid Plasma Reagin (RPR or Treponema pallidum antibody) test result at Screening.

20. Volunteer was in contact with the person who had a positive test result for COVID 19 within 14 days prior to Screening.

21. Presence of one or more of the following signs/symptoms at any time during the study: cough, sore throat, shortness of breath or difficulty breathing at rest or with activity, body pain or muscle pain/aches, fatigue, headache, fever or chills, nasal obstruction or congestion, nasal discharge, nausea or vomiting, diarrhea, new loss of taste or smell, if confirmed by positive SARS CoV 2 test (rapid test) result.

22. Known or suspected history of drug abuse as judged by the Investigator.

23. Positive screen for drugs of abuse (to include at minimum: amphetamine, methamphetamines, cannabis, cocaine, opiates, barbiturates, benzodiazepine, methadone, tricyclic antidepressants) or alcohol at Screening or at any of the admissions to the clinical unit.

24. Positive urinary cotinine test at Screening or at any of the admissions to the clinical unit.

25. Regular alcohol consumption within 6 months prior to Screening, defined as an average weekly intake of \>5 units of alcohol. One unit of alcohol is equivalent to: 500 mL of beer, 200 mL of dry wine or 50 mL of spirits.

26. Consumption of food containing poppy seeds within 72 h prior to Screening.

27. Any intake of red wine, Seville oranges, grapefruit or grapefruit juice, pomelos, exotic citrus fruits, grapefruit hybrids, or their juices within 7 days prior to the first administration of the IMP until collection of the final PK sample in this study.

28. Any intake of caffeine- or xanthine-containing products (e.g., coffee, tea, cola drinks, guaraná drinks, chocolate) within 48 h prior to the administration of the IMP until collection of the final PK sample during each dosing session.

29. Any intake of alcohol within 48 h prior to the administration of the IMP until collection of the final PK sample during each dosing session.

30. Participation in strenuous exercise within 48 h prior to the administration of the IMP until collection of the final PK sample during each dosing session.

31. Plasma donation within one month of Screening or any blood donation/blood loss \>500 mL during the 3 months prior to Screening or ≥50 mL and \<500 mL within 30 days prior to the first administration of the IMP.

32. The subject has participated in a clinical trial and has received an IMP within the following time period prior to the first administration of the IMP in the present study: 30 days, 5 half-lives or twice the duration of the biological effect of the IMP (whichever is longer), or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject's safety or the integrity of the study results.

33. Previous randomization to the IMP in the present study.

34. Known or ongoing psychiatric disorders that would interfere with study participation as determined by the Investigator.

35. Volunteer reports difficulty swallowing tablets whole.

36. Judgment by the Investigator that the healthy volunteer should not participate in the study if they are considered unlikely to comply with study procedures, restrictions, and requirements.

What this study is about