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

NCT05085587 | Unknown Phase 1 FDA Drug

• 1 other identifier: BECRO/RESP/BREATH-PK250-US-R
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bioequivalence; Asthma

Keywords

bioequivalence; fluticasone propionate; salmeterol xinafoate; ADVAIR

Outcome Measures

Primary Outcomes (4)

• Cmax for Fluticasone Propionate (FP)

  Maximum plasma concentration, it is read directly from the raw data

  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]

• Cmax for Salmeterol

  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]

• AUC(0-t) for Fluticasone Propionste (FP)

  Area under the plasma concentration curve from time 0 to the last measured concentration at time t

  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]

• AUC(0-t) for Salmeterol

  Area under the plasma concentration curve from time 0 to the last measured concentration at time t

  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 Outcomes (5)

• AUC0-∞

  up to 36 hours post-administration

• Tmax

  up to 36 hours post-administration

• t1/2

  up to 36 hours post-administration

• λz

  up to 36 hours post-administration

• Residual Area

  up to 36 hours post-administration

Study Arms (2)

Test Product

EXPERIMENTAL

Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals

Drug: Test

Reference Product

ACTIVE COMPARATOR

ADVAIR DISKUS 250/50

Drug: Reference

Interventions

Test DRUG

2 inhalations of Test and Reference product in each study period

Also known as: Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals

Test Product

Reference DRUG

2 inhalations of Test and Reference product in each study period

Also known as: ADVAIR DISKUS 250/50

Reference Product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers of both genders, aged ≥18 and ≤55 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) \>=90% 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 at reproductive age i.e.pre-menopausal or unable to gestate \[i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration\].
• 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.

You may not qualify if:

• 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 12 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 12 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
• 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.

Sponsors & Collaborators

• Respirent Pharmaceuticals Co Ltd.: lead
• Becro Ltd.: collaborator

Study Sites (1)

BECRO Clinical Facility

Larissa, Thessaly, 41100, Greece

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Chrysoula Doxani, MD, MSc, PhD

  Becro Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory blinded
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 20, 2021
• Study Start: October 1, 2021
• Primary Completion: October 25, 2021
• Study Completion: December 30, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)