A Bioequivalence Study Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers

NCT03975166 | Completed Phase 1

• 1 other identifier: BECRO/RESP/BREATH-PK100
• 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 (2)

• (AUC0-t)

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

• 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

  p to 36 hours post-administration

Study Arms (2)

Test Product

EXPERIMENTAL

Fluticasone propionate 100 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals

Drug: Test Product

Reference Product

ACTIVE COMPARATOR

ADVAIR DISKUS® 100/50

Drug: Reference Product

Interventions

Test Product DRUG

2 inhalations in one study period

Also known as: Fluticasone propionate 1000 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals

Test Product

Reference Product DRUG

2 inhalations in one study period

Also known as: ADVAIR DISKUS 100/50

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 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

• Ioannis Stefanidis, Professor

  University of Thessaly Department of Medicine

  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: June 3, 2019
• First Posted: June 5, 2019
• Study Start: May 21, 2019
• Primary Completion: June 25, 2019
• Study Completion: August 10, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)