- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546256
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
March 8, 2021 updated by: Respirent Pharmaceuticals Co Ltd.
A Pilot, Randomized, Single-dose, Open Label, Two-treatment, Two-sequence, Two-period, Crossover Study Under Fasting Conditions to Examine the Bioequivalence Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
ioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Study Overview
Status
Completed
Conditions
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 500 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 500/50 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
Interventional
Enrollment (Actual)
14
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Thessaly
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Larissa, Thessaly, Greece, 41100
- BECRO Clinical Facility
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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) [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
- 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 sub-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, intravaginal or transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation oral, implanable or injectable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Product
Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals
|
2 inhalations of Test and Reference product in each study period
|
Active Comparator: Reference Product
ADVAIR DISKUS® 500/50
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2 inhalations of Test and Reference product in each study period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax
Time Frame: up to 36 hours post-administration
|
Maximum plasma concentration, it is read directly from the raw data
|
up to 36 hours post-administration
|
AUC0-t
Time Frame: up to 36 hours post-administration
|
Area under the plasma concentration curve from time 0 to the last measured
|
up to 36 hours post-administration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC0-∞
Time Frame: up to 36 hours post-administration
|
Area under the plasma concentration-time curve extrapolated to infinity
|
up to 36 hours post-administration
|
Tmax
Time Frame: up to 36 hours post-administration
|
Time until Cmax is reached, it is read directly from the observed concentrations
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up to 36 hours post-administration
|
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
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up to 36 hours post-administration
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Residual area
Time Frame: up to 36 hours post-administration
|
[AUC(0-∞)-AUC(0-t)]/AUC(0-∞)]
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up to 36 hours post-administration
|
t1/2
Time Frame: up to 36 hours post-administration
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Plasma concentration halflife, it is calculated from the ratio 0.693/λZ.
|
up to 36 hours post-administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Actual)
September 25, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
September 6, 2020
First Submitted That Met QC Criteria
September 6, 2020
First Posted (Actual)
September 11, 2020
Study Record Updates
Last Update Posted (Actual)
March 9, 2021
Last Update Submitted That Met QC Criteria
March 8, 2021
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Respiration Disorders
- Respiratory Aspiration
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Sympathomimetics
- Fluticasone
- Xhance
- Salmeterol Xinafoate
- Fluticasone-Salmeterol Drug Combination
Other Study ID Numbers
- BECRO/RESP/BREATH-BE500-PILOT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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