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AsthmaPhase 1NCT02466503

Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block

A Phase 1 study testing Fluticasone propionate and Salmeterol (as xinafoate) in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Intech Biopharm Ltd. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
What is being tested?
Fluticasone propionate and Salmeterol (as xinafoate)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTaiwan
Study dates
Aug 2014to Sep 2014
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 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy male and female volunteers, aged 20-65, inclusive.
  • BMI that is within 18.0-30.0 kg/m², inclusive.
  • Healthy or Non Clinical Significant, according to the medical history, ECG, Chest X-ray and physical examination as determined by the Principal Investigator/Sub-Investigator.
  • Systolic blood pressure between 90-139 mmHg, inclusive, and diastolic blood pressure between 50-90 mmHg, inclusive, and pulse rate between 50-100 bpm, inclusive and temperature between 35.0-37.4℃.
  • Clinical laboratory values within PPC's acceptable range according to PPC SOP VI-006.
  • Ability to comprehend and be informed of the nature of the study, as assessed by PPC staff. Capable of giving written informed consent prior to receiving any study medication. Must be able to communicate effectively with clinic staff.
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  • Ability to fast for at least 14 hours and to consume standard meals.
  • Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements.
  • Agree not to have a tattoo or body piercing until the end of the study.
  • Female subjects must fulfill at least one of the following:
  • Be surgically sterile for a minimum of 6 months;
  • Post-menopausal for a minimum of 1 year;
  • Agree to avoid pregnancy and use medically acceptable method of contraception from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).

Who cannot join

  • Known history or presence of any clinically significant hepatic (e.g. active liver disease, hepatic impairment), renal/genitourinary (e.g. renal impairment), gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine (e.g. hypothyroidism), immunological, musculoskeletal (e.g. myopathy, rhabdomyolysis), neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the Principal Investigator/Sub-Investigator.
  • Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel disease), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug experienced within 7 days prior to first drug administration, as determined by the Principal Investigator/Sub-Investigator.
  • Presence of any clinically significant illness within 30 days prior to first dosing, as determined by the Principal Investigator/Sub-Investigator.
  • Presence of any significant physical or organ abnormality as determined by the Principal Investigator/Sub-Investigator.
  • A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, tetrahydrocannabinol), breath alcohol test. Positive pregnancy test for female subjects.
  • Known history or presence of:
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  • Alcohol abuse or dependence within one year prior to first drug administration;
  • Drug abuse or dependence;
  • Hypersensitivity or idiosyncratic reaction to fluticasone propionate, salmeterol xinafoate, its excipients, and/or related substances;
  • Food allergies and/or presence of any dietary restrictions;
  • Severe allergic reactions (e.g. anaphylactic reactions, angioedema).
  • Intolerance to and/or difficulty with blood sampling through venipuncture.
  • Abnormal diet patterns (for any reason) during the four weeks preceding the study, including fasting, high protein diets etc.
  • Individuals who have donated, in the days prior to first drug administration:
  • Less than 250 mL of blood in the previous 60 days
  • 300 mL or more in the previous 90 days
  • Donation of plasma by plasmapheresis within 7 days prior to first drug administration.
  • Individuals who have participated in another clinical trial or who received an investigational drug within 30 days prior to first drug administration.
  • Consumption of food or beverages containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and containing grapefruit and/or pomelo within 10 days prior to first drug administration.
  • Use of any prescription medication or investigational medication within 30 days prior to first drug administration.
  • Use of any over-the-counter medications (including oral multivitamins, herbal and/or dietary supplements) within 30 days prior to first drug administration (except for spermicidal/barrier contraceptive products).
  • Females taking oral or transdermal hormonal contraceptives within 30 days prior to first drug administration.
  • Females having used implanted, injected, intravaginal, or intrauterine hormonal contraceptive within 6 months prior to first drug administration.
  • Individuals having undergone any major surgery within 6 months prior to the start of the study, unless deemed otherwise by Principal Investigator/Sub-Investigator.
  • Known history of smoking or using tobacco products, nicotine products (patches, gum etc.) within 6 months prior to first drug administration.
  • Pregnant/lactating women.
  • Subjects will be given training to ensure that subjects are able to correctly use the investigational products in screening. The subjects who are unable to operate the investigational products proficiently will not be included in this study.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Clinical Pharmacology Unit of Mackay Memorial Hospital Tamshui Branch

    New Taipei City

Other trials in Taiwan

About this study

Official title: A Single-Dose, Randomized, Open-Label, Crossover, Pivotal, Comparative Bioavailability Study of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in Healthy Volunteers With Charcoal Block

The objective of this pivotal study is to evaluate the relative bioavailability of Synflutide HFA 250/25 Inhaler and SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block.

Read the detailed description

A pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment, crossover, comparative bioavailability study for test drug Synflutide HFA 250/25 Inhaler and reference drug SeretideTM 250 EvohalerTM in healthy volunteers with charcoal block. Fifty healthy, male and female volunteers, 20-65 years of age, with a body mass index (BMI) within 18.0-30.0 kg/m2, inclusive, will be enrolled. A single dose of 4 puffs (eq. to fluticasone propionate 1000μg+salmeterol 100μg from valve) in each study period. Plasma samples will be assayed for fluticasone propionate and salmeterol using a validated analytical method according to the principles of Good Laboratory Practice.

Being tested
Fluticasone propionate, Salmeterol (as xinafoate)
Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluticasone propionateDrug

    Also called Flovent, Flixotide

    Inhaled corticosteroid, pMDI

  • Salmeterol (as xinafoate)Drug

    Also called Serevent

    Beta-agonist, LABA, pMDI

Study groups in NCT02466503
Study groupRoleWhat they receive
Synflutide HFA MDI, 250/25 mcg/doseExperimentalSynflutide HFA MDI(Fluticasone propionate/ Salmeterol, 250/25mcg), Single dose, 4 puffs
Receives: Drug: Fluticasone propionate; Drug: Salmeterol (as xinafoate)
SeretideTM EvohalerTM, 250/25 mcg/doseActive comparatorSeretideTM EvohalerTM (Fluticasone propionate/ Salmeterol, 250/25mcg), Single dose, 4 puffs
Receives: Drug: Fluticasone propionate; Drug: Salmeterol (as xinafoate)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under Curve (AUC)

    Measured: Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing

  2. Maximum plasma concentration (Cmax)

    Measured: Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing

Secondary outcomes (3)

  1. Time to reach Maximum plasma concentration (Tmax)

    Measured: Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing

  2. blood pressure [BP]

    Measured: pre-dose and 0.5, 2 and 24 hours after dosing

  3. pulse rate [PR]

    Measured: pre-dose and 0.5, 2 and 24 hours after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2015 (estimated)
  2. Study startAug 2014
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02466503
Sponsor's protocol ID
MCPE14015M1
Status last verified
Jun 2015
First submitted
2 Jun 2015
Last updated
9 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fluticasone propionate and Salmeterol (as xinafoate) in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Intech Biopharm Ltd. at 1 site in Taiwan.

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 13 inclusion and 27 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 9 Jun 2015. 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 Taiwan. 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 Curve (AUC) (time frame: Pre-dose and at 0.08, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours after dosing). 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?

On the ClinicalTrials.gov record for NCT02466503.

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 9 Jun 2015.

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