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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

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ClinicalTrials.gov Identifier: NCT03975166
Recruitment Status : Active, not recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
BECRO Ltd.
Information provided by (Responsible Party):
Respirent Pharmaceuticals Co Ltd.

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

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Test Product Drug: Reference Product Phase 1

Detailed Description:
A bioequivalence study of a single dose of the fixed-dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder administered from Fluticasone propionate 100 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 100/50 mcg inhalation powder/GSK (reference-R) 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Masking Description: laboratory-blinded
Primary Purpose: Other
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 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 Inhalation Powder/GSK in Healthy Volunteers
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : June 25, 2019
Estimated Study Completion Date : July 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test Product
Fluticasone propionate 100 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals
Drug: Test Product
2 inhalations in one study period
Other Name: Fluticasone propionate 1000 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals

Active Comparator: Reference Product
ADVAIR DISKUS® 100/50
Drug: Reference Product
2 inhalations in one study period
Other Name: ADVAIR DISKUS 100/50




Primary Outcome Measures :
  1. (AUC0-t) [ Time Frame: up to 36 hours post-administration ]
    Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)

  2. Cmax [ Time Frame: up to 36 hours post-administration ]
    Maximum plasma concentration, it is read directly from the raw data


Secondary Outcome Measures :
  1. AUC0-∞ [ Time Frame: up to 36 hours post-administration ]
    Area under the plasma concentration-time curve extrapolated to infinity

  2. Tmax [ Time Frame: up to 36 hours post-administration ]
    Time until Cmax is reached, it is read directly from the observed concentrations

  3. t1/2 [ Time Frame: up to 36 hours post-administration ]
    Plasma concentration halflife, it is calculated from the ratio 0.693/λZ.

  4. λz [ Time Frame: up to 36 hours post-administration ]
    Terminal elimination rate constant, calculated from the slope of the final phase of the ln-concentration curve versus time with regression analysis

  5. Residual area [ Time Frame: p to 36 hours post-administration ]
    [AUC(0-∞)-AUC(0-t)]/AUC(0-∞)]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

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) [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
  • 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 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
  • Females of reproductive age that had sexual intercourse with a non-sterile male partner without protection within 14 days prior to drug administration

Reliable contraception methods are considered the following:

combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral or transdermal progestogen-only hormonal contraception associated with inhibition of ovulation oral or injectable bilateral tubal occlusion vasectomised partner sexual abstinence


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975166


Locations
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Greece
BECRO Clinical Facility
Larissa, Thessaly, Greece, 41100
Sponsors and Collaborators
Respirent Pharmaceuticals Co Ltd.
BECRO Ltd.
Investigators
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Principal Investigator: Ioannis Stefanidis, Professor University of Thessaly Department of Medicine

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Responsible Party: Respirent Pharmaceuticals Co Ltd.
ClinicalTrials.gov Identifier: NCT03975166     History of Changes
Other Study ID Numbers: BECRO/RESP/BREATH-PK100
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Respirent Pharmaceuticals Co Ltd.:
bioequivalence
fluticasone propionate
salmeterol xinafoate
ADVAIR

Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics