A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. ADVAIR DISKUS® in Healthy Volunteers

NCT03751202 | Completed Phase 1 FDA Drug

• 1 other identifier: BECRO/RESP/BREATH-PK500
• 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

inhaler; fluticasone proprionate; salmeterol xinafoate; ADVAIR DISKUS

Outcome Measures

Primary Outcomes (2)

• Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)

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

  up to 36 hours post-administration

• Cmax

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

  up to 36 hours post-administration

Secondary Outcomes (5)

• Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)

  up to 36 hours post-administration

• Tmax

  up to 36 hours post-administration

• t1/2

  up to 36 hours post-administration

• Terminal elimination rate constant (λz)

  up to 36 hours post-administration

• Residual area

  up to 36 hours post-administration

Study Arms (2)

Test product

EXPERIMENTAL

Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals

Drug: Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg

Reference product

ACTIVE COMPARATOR

ADVAIR DISKUS® 500/50

Drug: ADVAIR DISKUS

Interventions

Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg DRUG

2 inhalations of Test and Reference product in each study period

Also known as: Fluticasone propionate 500mcg and salmeterol xinafoate 50mcg/Respirent Pharmaceuticals

Test product

ADVAIR DISKUS DRUG

2 inhalations of Test and Reference product in each study period

Also known as: Fluticasone propionate 500mcg and salmeterol xinafoate 50mcg

Reference product

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 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 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) \[1 Unit =150 ml of wine, 360 ml of beer, or 45 ml of 40% alcohol\].
• 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; Fluticasone-Salmeterol Drug Combination

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ioannis Stefanidis, Professor

  University of Larissa School of Medicine

  PRINCIPAL INVESTIGATOR

• 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
• 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: November 15, 2018
• First Posted: November 23, 2018
• Study Start: November 20, 2018
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: December 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)