Systemic exposure bioequivalence study between two formulations of orally inhaled fluticasone propionate and salmeterol xinafoate.

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201508001221356
• Date of registration: 27/07/2015
• Prospective Registration: Yes
• Primary sponsor: Prosonix Limited
• Public title: Systemic exposure bioequivalence study between two formulations of orally inhaled fluticasone propionate and salmeterol xinafoate.
• Scientific title: A single center, single dose, open label, randomized, two period crossover study to determine the bioequivalence of two formulations containing fluticasone propionate and salmeterol xinafoate 250/25 mcg per actuation, administered from a pressurized metered dose inhaler (pMDI) via a valved holding chamber, in at least 60 healthy male and female subjects without charcoal under fasting conditions
• Date of first enrolment: 10/09/2015
• Target sample size: 60
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1221
• Study type: Interventional
• Study design: Crossover: all participants receive all interventions in different sequence during study,Randomised,SAS software PROC PLAN procedure,Allocation to be determined by off-site holder of the sequence
• Phase: Not Applicable

Countries of recruitment

South Africa

Contacts

• Name: Geoff Down
• Affiliation: Chief Medical Officer

• Name: Lizette Herbst
• Affiliation: Clinical Project Manager

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy male and female subjects, 18 years (inclusive) and older
2. Body Mass Index (BMI) between 18.5 (inclusive) and 30 kg/m2
3. Body mass not less than 50 kg for males and 52 kg for females
4. Medical history, vital signs, physical examination, standard 12-lead 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., has been surgically sterilized, undergone a hysterectomy, amenorrhea for = 12 months and considered post menopausal, Note: In postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
OR
¿ Of childbearing potential, the following conditions are to be met:
- Negative pregnancy test. If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IMP, every attempt must be made to follow her to term.
- Not lactating
- Abstaining from sexual activity (if this is the usual lifestyle of the subject) or must agree to use an accepted method of contraception and agree to continue with the same method throughout the study. Examples of reliable methods of contraception include non hormonal intrauterine device and barrier methods combined with an additional contraceptive method. In this study the concomitant use of hormonal contraceptives is NOT allowed. 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. Evidence of psychiatric disorder, or disorders limiting the ability to comply with protocol requirements.
2. Current alcohol use > 21 units of alcohol per week for males and > 14 units of alcohol per week for females.
3. Regular exposure to substances of abuse (other than alcohol) within the past year.
4. Use of any medication, prescribed or over the counter or herbal remedies, within two weeks prior to the first administration of IMP except if this will not affect the outcome of the study. Cconcomitant use of hormonal contraceptives is NOT allowed.
5. Participation in another study with an experimental drug, where the last administration of the previous IMP was within eight weeks before the first administration of IMP in this study.
6. Treatment within the previous three months before the first administration of IMP with any drug with a well defined potential for adversely affecting a major organ or system.
7. A major illness during the three months before commencement of the screening period.
8. History of hypersensitivity or allergy to the IMP or its excipients or any related medication.
9. History of bronchial asthma or any other bronchospastic disease.
10. History of epilepsy, porphyria, cataracts, glaucoma or oral candida.
11. Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
12. Hypokalaemia
13. Relevant conditions that can decrease the potassium levels.
14. Donation or loss of blood equal to or exceeding 500 mL during the eight weeks before the first administration of IMP.
15. Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
16. Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
17. Positive testing for HIV, hepatitis B or hepatitis C.
18. Positive urine screen for drugs of abuse or tobacco use.
19. Positive pregnancy test.
20. Serum levels of = 2x upper limit of the normal range for alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase (ALP) AND/OR serum levels of = 2x upper limit for total bilirubin.
21. Unable to demonstrate proper inhalation techniques.
22. Immunization using a live organism vaccine within four weeks prior to the first dosing of IMP.
23. Forced expiratory volume in 1 second (FEV1) ¿ 80% of the predicted value regarding age, height, gender and ethnicity.

Age minimum: 18 Year(s)
Age maximum: 65 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

Respiratory
Healthy subjects, intended disorder is asthma

Healthy subjects, intended disorder is asthma

Respiratory

Intervention(s)

Prosonix fluticasone propionate 50mcg per actuation + salmeterol xinafoate 25mcg per actuation

Seretide Evohaler fluticasone propionate 50mcg + salmeterol xinafoate 25mcg per actuation

Primary Outcome(s)

Plasma fluticasone propionate and salmeterol xinafoate levels

Secondary ID(s)

PSX2005-05 / PXL221464

Source(s) of Monetary Support

Prosonix Limited

Ethics review

Status: Approved
Approval date: 29/06/2015
Contact:

University of the Free State Ethics Committee