Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers

NCT05982990 | Unknown Phase 1 FDA Drug

• 1 other identifier: BECRO/RESP/AEROPK250
• Study Type: interventional
• Target: 34
• 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

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

  up to 36 hours post-administration

• Cmax for Salmeterol

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

  up to 36 hours post-administration

• (AUC0-t) for Fluticasone Propionate (FP)

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

  up to 36 hours post-administration

• AUC0-t for Salmeterol

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

  up to 36 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)

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

EXPERIMENTAL

Test

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

ADVAIR DISKUS® 250/50

ACTIVE COMPARATOR

Reference

Drug: ADVAIR DISKUS® 250/50

Interventions

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

2 inhalations in one study period

Also known as: Test

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

ADVAIR DISKUS® 250/50 DRUG

2 inhalations in one study period

Also known as: Reference

ADVAIR DISKUS® 250/50

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 the first 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, implantable 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

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 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
• 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

Interventions

Fluticasone; Salmeterol Xinafoate

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: August 1, 2023
• First Posted: August 9, 2023
• Study Start: August 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 20, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

GR (1)