BioequivalencePhase 1BREATH-PK500NCT03751202
A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. ADVAIR DISKUS® in Healthy Volunteers
A Phase 1 study testing Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg and ADVAIR DISKUS in people with Bioequivalence, run by Respirent Pharmaceuticals Co Ltd. at 1 site in Greece.
Trial summary
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg and ADVAIR DISKUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteGreece
- Study dates
- 20 Nov 2018to 11 Dec 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
- 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 or transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation oral or injectable
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence
Trial locations and contacts
1 site in 1 country.
About this study
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 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Read the 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.
- Conditions
- Bioequivalence
- Being tested
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg, ADVAIR DISKUS
- Keywords
- inhaler, fluticasone proprionate, salmeterol xinafoate, ADVAIR DISKUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcgDrug
Also called Fluticasone propionate 500mcg and salmeterol xinafoate 50mcg/Respirent Pharmaceuticals
2 inhalations of Test and Reference product in each study period
ADVAIR DISKUSDrug
Also called Fluticasone propionate 500mcg and salmeterol xinafoate 50mcg
2 inhalations of Test and Reference product in each study period
| Study group | Role | What they receive |
|---|---|---|
| Test product | Experimental | Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals Receives: Drug: Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg |
| Reference product | Active comparator | ADVAIR DISKUS® 500/50 Receives: Drug: ADVAIR DISKUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 36 hours post-administration
Cmax
Maximum plasma concentration, it is read directly from the raw data
Measured: up to 36 hours post-administration
Secondary outcomes (5)
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
Area under the plasma concentration-time curve extrapolated to infinity
Measured: up to 36 hours post-administration
Tmax
Time until Cmax is reached, it is read directly from the observed concentrations
Measured: up to 36 hours post-administration
t1/2
Plasma concentration halflife, it is calculated from the ratio 0.693/λZ
Measured: up to 36 hours post-administration
Terminal elimination rate constant (λz)
Terminal elimination rate constant, calculated from the slope of the final phase of the ln-concentration curve versus time with regression analysis
Measured: up to 36 hours post-administration
Residual area
[AUC(0-∞)-AUC(0-t)]/AUC(0-∞)]
Measured: up to 36 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start20 Nov 2018
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Respirent Pharmaceuticals Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Becro Ltd.
- Responsible party
- Sponsor
- Investigators
- Ioannis Stefanidis, Professor, Principal investigator, University of Larissa School of MedicineChrysoula Doxani, MD, MSc, PhD, Principal investigator, Becro Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751202
- Sponsor's protocol ID
- BECRO/RESP/BREATH-PK500
- Acronym
- BREATH-PK500
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 28 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03751202
- Acronym / sponsor ID
- BREATH-PK500 / BECRO/RESP/BREATH-PK500
- Conditions
- Bioequivalence
- Keywords
- inhaler, fluticasone proprionate, salmeterol xinafoate, ADVAIR DISKUS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Respirent Pharmaceuticals Co Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Becro Ltd.
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
| Arm | Type | Receives |
|---|---|---|
| Test product | Experimental | Drug: Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcgFluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals |
| Reference product | Active comparator | Drug: ADVAIR DISKUSADVAIR DISKUS® 500/50 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcgAlso: Fluticasone propionate 500mcg and salmeterol xinafoate 50mcg/Respirent Pharmaceuticals2 inhalations of Test and Reference product in each study period | Drug | Test product |
| ADVAIR DISKUSAlso: Fluticasone propionate 500mcg and salmeterol xinafoate 50mcg2 inhalations of Test and Reference product in each study period | Drug | Reference product |
Primary outcome
Area under the plasma concentration curve from time 0 to the last measured (AUC0-t)
Time frame: up to 36 hours post-administration
Area under the plasma concentration curve from time 0 to the last measured concentration at time t
Cmax
Time frame: up to 36 hours post-administration
Maximum plasma concentration, it is read directly from the raw data
5 secondary outcomes
Area under the plasma concentration-time curve extrapolated to infinity (AUC0-∞)
Time frame: up to 36 hours post-administration
Tmax
Time frame: up to 36 hours post-administration
t1/2
Time frame: up to 36 hours post-administration
Terminal elimination rate constant (λz)
Time frame: up to 36 hours post-administration
Residual area
Time frame: up to 36 hours post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Stefanidis, Professor principal investigator
University of Larissa School of Medicine
Chrysoula Doxani, MD, MSc, PhD principal investigator
Becro Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg and ADVAIR DISKUS in people with Bioequivalence, run by Respirent Pharmaceuticals Co Ltd. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration curve from time 0 to the last measured (AUC0-t) (time frame: up to 36 hours post-administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2018.