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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 : Completed
First Posted : June 5, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
BECRO Ltd.
Information provided by (Responsible Party):
Respirent Pharmaceuticals Co Ltd.

Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE May 21, 2019
Actual Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • (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)
  • Cmax [ Time Frame: up to 36 hours post-administration ]
    Maximum plasma concentration, it is read directly from the raw data
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03975166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • AUC0-∞ [ Time Frame: up to 36 hours post-administration ]
    Area under the plasma concentration-time curve extrapolated to infinity
  • Tmax [ Time Frame: up to 36 hours post-administration ]
    Time until Cmax is reached, it is read directly from the observed concentrations
  • t1/2 [ Time Frame: up to 36 hours post-administration ]
    Plasma concentration halflife, it is calculated from the ratio 0.693/λZ.
  • 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
  • Residual area [ Time Frame: p to 36 hours post-administration ]
    [AUC(0-∞)-AUC(0-t)]/AUC(0-∞)]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Bioequivalence
Intervention  ICMJE
  • Drug: Test Product
    2 inhalations in one study period
    Other Name: Fluticasone propionate 1000 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals
  • Drug: Reference Product
    2 inhalations in one study period
    Other Name: ADVAIR DISKUS 100/50
Study Arms  ICMJE
  • Experimental: Test Product
    Fluticasone propionate 100 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals
    Intervention: Drug: Test Product
  • Active Comparator: Reference Product
    ADVAIR DISKUS® 100/50
    Intervention: Drug: Reference Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2019)
34
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 10, 2019
Actual Primary Completion Date June 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975166
Other Study ID Numbers  ICMJE BECRO/RESP/BREATH-PK100
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Respirent Pharmaceuticals Co Ltd.
Study Sponsor  ICMJE Respirent Pharmaceuticals Co Ltd.
Collaborators  ICMJE BECRO Ltd.
Investigators  ICMJE
Principal Investigator: Ioannis Stefanidis, Professor University of Thessaly Department of Medicine
PRS Account Respirent Pharmaceuticals Co Ltd.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP