A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers

March 8, 2021 updated by: Respirent Pharmaceuticals Co Ltd.

A Pilot, Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers

ioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

Study Overview

Detailed Description

A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 500 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 500/50 mcg inhalation powder/GSK (reference-R) in healthy volunteers under fasting conditions. The study will be one-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Thessaly
      • Larissa, Thessaly, Greece, 41100
        • BECRO Clinical Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy volunteers of both genders, aged ≥18 and ≤60 years.
  2. Subjects with Body Mass Index (ΒΜΙ) ≥18.5 and <30.0 kg/m2.
  3. Healthy volunteers are declared healthy based on medical history, physical examination, ECG, pulmonary function test (a forced expiratory volume in 1 second (FEV1) ≥80% of the predicted normal value), and clinical laboratory values within the laboratory stated normal range; if not within this range, they must be without any clinical significance according to the Investigator.
  4. Females who participate in the study are either at reproductive age i.e.pre-menopausal or unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration].
  5. Subjects that are non-smokers.
  6. Subjects that, in the opinion of the principal investigator/medical officer, are able to communicate and comply with the study procedures and protocol restrictions as evidenced by the Informed Consent Form (ICF) duly read, signed and dated by the subject prior to study initiation.
  7. Subjects able to use the inhalers according to given instructions, as judged by the Investigator or study nurse.

Exclusion Criteria:

  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 four 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 4 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 four 4 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Product
Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals
2 inhalations of Test and Reference product in each study period
Active Comparator: Reference Product
ADVAIR DISKUS® 500/50
2 inhalations of Test and Reference product in each study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: up to 36 hours post-administration
Maximum plasma concentration, it is read directly from the raw data
up to 36 hours post-administration
AUC0-t
Time Frame: up to 36 hours post-administration
Area under the plasma concentration curve from time 0 to the last measured
up to 36 hours post-administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC0-∞
Time Frame: up to 36 hours post-administration
Area under the plasma concentration-time curve extrapolated to infinity
up to 36 hours post-administration
Tmax
Time Frame: up to 36 hours post-administration
Time until Cmax is reached, it is read directly from the observed concentrations
up to 36 hours post-administration
λz
Time Frame: up to 36 hours post-administration
Terminal elimination rate constant, calculated from the slope of the final phase of the ln-concentration curve versus time with regression analysis
up to 36 hours post-administration
Residual area
Time Frame: up to 36 hours post-administration
[AUC(0-∞)-AUC(0-t)]/AUC(0-∞)]
up to 36 hours post-administration
t1/2
Time Frame: up to 36 hours post-administration
Plasma concentration halflife, it is calculated from the ratio 0.693/λZ.
up to 36 hours post-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

September 25, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

September 6, 2020

First Submitted That Met QC Criteria

September 6, 2020

First Posted (Actual)

September 11, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

September 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bioequivalence

Clinical Trials on Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent

3
Subscribe