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A Bioequivalence Study Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions

Primary Purpose

Asthma, Bioequivalence

Status
Active
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals
FLOVENT DISKUS
Sponsored by
Respirent Pharmaceuticals Co Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma focused on measuring bioequivalence, FLOVENT, fluticasone propionate, asthma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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 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] or at reproductive age; Females of reproductive age if sexually active, must be practicing an effective method of birth control within 14 days prior to drug administration and throughout the study.

    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

  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

Sites / Locations

  • BECRO Clinical Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test

Reference

Arm Description

Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals

FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK

Outcomes

Primary Outcome Measures

Cmax
Maximum plasma concentration, it is read directly from the raw data
AUC(0-t)
Area under the plasma concentration curve from time 0 to the last measured

Secondary Outcome Measures

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

Full Information

First Posted
May 25, 2022
Last Updated
May 25, 2022
Sponsor
Respirent Pharmaceuticals Co Ltd.
Collaborators
Becro Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05397834
Brief Title
A Bioequivalence Study Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions
Official Title
A Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
June 21, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Respirent Pharmaceuticals Co Ltd.
Collaborators
Becro Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder
Detailed Description
A bioequivalence study of a single dose of Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bioequivalence
Keywords
bioequivalence, FLOVENT, fluticasone propionate, asthma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking
Outcomes Assessor
Masking Description
laboratory-blinded study
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals
Arm Title
Reference
Arm Type
Active Comparator
Arm Description
FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals
Other Intervention Name(s)
Test
Intervention Description
2 inhalations of Test and Reference product in each study period
Intervention Type
Drug
Intervention Name(s)
FLOVENT DISKUS
Other Intervention Name(s)
Reference
Intervention Description
2 inhalations of Test and Reference product in each study period
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum plasma concentration, it is read directly from the raw data
Time Frame
3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration]
Title
AUC(0-t)
Description
Area under the plasma concentration curve from time 0 to the last measured
Time Frame
3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration
Secondary Outcome Measure Information:
Title
AUC0-∞
Description
Area under the plasma concentration-time curve extrapolated to infinity
Time Frame
3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration
Title
Tmax
Description
Time until Cmax is reached, it is read directly from the observed concentrations
Time Frame
3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration
Title
t1/2
Description
Plasma concentration halflife, it is calculated from the ratio 0.693/λZ
Time Frame
3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration
Title
λz
Description
Terminal elimination rate constant, calculated from the slope of the final phase of the ln-concentration curve versus time with regression analysis
Time Frame
3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration
Title
Residual Area
Description
[AUC(0-∞)-AUC(0-t)]/AUC(0-∞)]
Time Frame
3, 5, 10, 15, 30, 45 minutes, 1.00 hour, 1 hour and 20 minutes, 1 hour and 40 minutes, 2.00 hours, 2 hours and 30 minutes, 3.00, 4.00, 6.00, 8.00, 12.00, 14.00, 16.00, 24.00 and 36:00 hours post-administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers of both genders, aged ≥18 and ≤60 years. Subjects with Body Mass Index (ΒΜΙ) ≥18.5 and <30.0 kg/m2. 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. Females who participate in the study are either 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] or at reproductive age; Females of reproductive age if sexually active, must be practicing an effective method of birth control within 14 days prior to drug administration and throughout the study. 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 Subjects that are non-smokers. 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. Subjects able to use the inhalers according to given instructions, as judged by the Investigator or study nurse. Exclusion Criteria: 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 Clinically significant illness or surgery within four weeks prior to dosing. 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. Clinically significant history or presence of chronic bronchitis, emphysema,asthma or any other lung disease. History or presence of pulmonary tuberculosis. Viral or bacterial, upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit. History or presence of significant cardiovascular, endocrinal, neurologic, immunological, psychiatric or metabolic disease. History of significant alcohol or drug abuse within one year prior to the screening visit. 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]. Inability to abstain from alcohol for the duration of study period. Presence of disease markers for Hepatitis B, Hepatitis C or HIV at screening. Positive results for drugs of abuse (barbiturates, marijuana, opioids, benzodiazepines and methadone) in saliva before each administration. Positive alcohol breath test before each administration. 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 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. 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. Use of oral or parenteral corticosteroids in the previous four 4 weeks Eye disorders especially Glaucoma (or a family history of glaucoma) 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. Vaccination for prophylaxis from seasonal flu or any other vaccination within seven days prior to administration 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. A depot injection or an implant of any drug (except hormonal contraceptives) within 3 months prior to treatment administration. Donation of plasma (500 ml) within 7 days prior to treatment administration. 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. Participation in another clinical trial simultaneously. Subjects receiving special diet or having intolerance in any of the provided study meals or refusing to eat the study meals Application of tattoo or body piercing within 30 days prior to treatment administration. Non-tolerance to venipuncture. Breastfeeding women. Positive pregnancy test at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chrysoula Doxani, MD, MSc, PhD
Organizational Affiliation
Becro Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
BECRO Clinical Facility
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
41100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Bioequivalence Study Between Fluticasone Propionate 250 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 250 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions

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