Bioequivalence Study of Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 250/50 Inhalation Powder/GSK in Healthy Volunteers

1. Hypersensitivity to the active substance(s) or to the excipient (lactose which contains small amounts of milk protein may cause allergic reactions) or related class (any sympathomimetic drug or any inhaled, intranasal, or systemic corticosteroid therapy) of the medicinal product

2. Clinically significant illness or surgery within 12 weeks prior to dosing.

3. Clinically significant ECG abnormalities or vital sign abnormalities (seated systolic blood pressure \<90 or \>140 mmHg, seated diastolic blood pressure \<50 or \>90 mmHg or heart rate less than 50 or over 100 bpm) at screening.

4. Clinically significant history or presence of chronic bronchitis, emphysema,asthma or any other lung disease.

5. History or presence of pulmonary tuberculosis.

6. Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 12 weeks prior to the screening visit.

7. History or presence of significant cardiovascular, endocrinal, neurologic, immunological, psychiatric or metabolic disease.

8. History of significant alcohol or drug abuse within one year prior to the screening visit.

9. Regular use of alcohol within six months prior to screening visit (more than 14 alcohol units per week) \[1Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol\].

10. Inability to abstain from alcohol for the duration of study period.

11. Presence of disease markers for Hepatitis B, Hepatitis C or HIV at screening.

12. Positive results for drugs of abuse (barbiturates, marijuana, opioids, benzodiazepines and methadone) in saliva before each administration.

13. Positive alcohol breath test before each administration.

14. Use of soft drugs (such as marijuana) within three months prior to screening or hard drugs such as crack, cocaine or heroin within one year prior to screening visit

15. Intake of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers are barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors are, erythromycin, ketoconazole, indinavir, cobicistat-containing products) within one month prior to administration of the study medication. Under these circumstances, subject inclusion will be judged by the principal investigator.

16. History of peptic ulcer, other gastrointestinal disorders (e.g. chronic diarrhoea, irritable bowel syndrome) or unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting) or significant hepatic, renal or other condition that is known to interfere with the absorption, distribution, metabolism or excretion of the drug.

17. Use of oral or parenteral corticosteroids in the previous twelve (12) weeks

18. Eye disorders especially Glaucoma (or a family history of glaucoma)

19. Use of prescription medication (within 14 days prior to the first administration of study medication) or over-the-counter (OTC) products (including food supplements vitamins and herbal supplements) within one week (7 days) prior to the first administration of study medication, except for topical products without systematic absorption. Contraceptives are allowed.

20. Vaccination for prophylaxis from seasonal flu or any other vaccination within seven days prior to administration

21. History of allergy to any food, intolerance or special diet, that in the opinion of the medical sub-investigator could contraindicate the subject's participation in the study.

22. A depot injection or an implant of any drug (except hormonal contraceptives) within 3 months prior to treatment administration.

23. Donation of plasma (500 ml) within 7 days prior to treatment administration.

24. Donation of whole blood or loss of whole blood ≥ 500 ml prior to administration of the study medication within 30 days prior to treatment administration.

25. Participation in another clinical trial simultaneously.

26. Subjects receiving special diet or having intolerance in any of the provided study meals or refusing to eat the study meals

27. Application of tattoo or body piercing within 30 days prior to treatment administration.

28. Non-tolerance to venipuncture.

29. Breastfeeding women.

30. Positive pregnancy test at screening

31. Females of reproductive age that had sexual intercourse with a non-sterile male partner without protection within 14 days prior to drug administration

Reliable contraception methods are considered the following:

combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal

progestogen-only hormonal contraception associated with inhibition of ovulation oral, implanable or injectable

intrauterine device (IUD)

intrauterine hormone-releasing system (IUS)

bilateral tubal occlusion

vasectomised partner

sexual abstinence

What this study is about