Systemic exposure study between three formulations of orally inhaled fluticasone propionate and salmeterol xinafoate

Not Applicable

Completed

• Conditions: Respiratory; Healthy subjects, intended disorder is asthma

• Registration Number: PACTR201608001741317
• Lead Sponsor: Circassia Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Healthy male and female subjects, 18 years and older;
2. Body mass index (BMI) between 18.5 and 30 kg/m2 (both inclusive);
3. Body mass not less than 52 kg for males and 57 kg for females;
4. Medical history, vital signs, physical examination, standard 12 lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the Investigator considers the deviation to be irrelevant for the purpose of the study;
5. Non-smokers;
6. Females, if: Not of childbearing potential, e.g., been surgically sterilised, undergone hysterectomy, amenorrhea for ¿ 12 months and considered post menopausal; OR Of childbearing potential, following conditions to be met: Negative pregnancy test; If test positive, subject will be excluded from study. In rare circumstance that pregnancy discovered after subject receives IMP, every attempt must be made to follow her to term; Not lactating; Abstaining from sexual activity (if this is usual lifestyle of subject) or must agree to use accepted method of contraception, and agree to continue with same method throughout the study; Examples of reliable methods of contraception include non hormonal intrauterine device, barrier methods combined with additional contraceptive method; Other methods, if considered by the Investigator as reliable, will be accepted;
7. Subjects with normal potassium levels (according to local laboratory reference ranges);
8. Written consent given for participation in the study.

Exclusion Criteria

1. Psychiatric disorder or emotional, personality or intellectual problems likely to limit ability to consent or comply with study requirements;
2. Excess alcohol use;
3. Regular exposure to substances of abuse (other than alcohol) within past year;
4. Use within 2 weeks before IMP administration of any medication or other remedies that may interfere with the conduct or results of the study;
5. Concomitant use of hormonal replacement therapy or hormonal contraceptives;
6. Participation in a clinical investigation within 8 weeks before IMP administration in this study;
7. Use of any drug with well-defined potential for adversely affecting any organ or system, within 3 months before IMP administration;
8. Major illness in 3 months before start of screening;
9. History of hypersensitivity or allergy to IMP, excipients or related medication;
10. History of asthma or other bronchospastic disease;
11. History of epilepsy, porphyria, or current cataracts or glaucoma;
15. History of oral candida requiring treatment in last 3 years;
16. History, laboratory or clinical findings indicative of disease likely to influence study outcomes;
17. Conditions causing hypokalemia;
18. Blood loss equal to or exceeding 500 mL within 8 weeks before IMP administration;
19. Hypotension diagnosed at screening;
20. Current hypertension or diagnosis at screening;
21. Resting tachy- or bradycardia at screening;
22. Positive HIV, Hepatitis B or Hepatitis C tests;
23. Positive urinary drugs of abuse or cotinine;
24. Positive pregnancy test;
25. Inadequate inhalation technique at screening;
26. FEV1 < 80% predicted value;
27. Immunisation with live vaccine within 4 weeks before IMP administration;
28. Vulnerable subjects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
single-dose pharmacokinetic (PK) profiles for the test products 1: (PSX2005 E2 50/25) and 2: (PSX2005 M1 50/25), fluticasone propionate/salmeterol (as xinafoate) 50/25 µg per actuation via metered dose pressurised inhalation (pDMI), and the reference product, Seretide® Evohaler® 50/25 µg per actuation via pMDI, under fasting conditions in healthy male and female subjects.