AsthmaPhase 1NCT04494321
A Bioequivalence Pivotal Study of SYN010 HFA Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block
A Phase 1 study testing Budesonide and Formoterol in people with Asthma and COPD, run by Intech Biopharm Ltd. at 1 site in Taiwan.
Trial summary
The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA Inhaler and Symbicort 160/4.5μg in healthy volunteers without charcoal block. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- What is being tested?
- Budesonide and Formoterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Jun 2017to 17 Nov 2017
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers, aged 20-45, inclusive.
- BMI that is within 18.5-30.0 kg/m², inclusive. (The body weight should be over 50 kg, inclusive, respectively)
- Healthy or Non Clinical Significant, according to the medical history, Electrocardiography (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°C.
- Clinical laboratory values within reference range or Non-Clinical Significance (NCS) judged by the Principal Investigator/Sub-Investigator.
- Ability to comprehend and be informed of the nature of the study. 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 screening day until 30 days after study has ended (last study procedure). Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide). Complete abstinence alone can be used as a method of contraception.
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: Human immunodeficiency virus (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 budesonide, formoterol fumarate dihydrate , 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 and 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 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
About this study
Official title: A Single-Dose, Randomized, Open-Label, Two-Treatment, Three-Period, Three-Sequence, Three-Way Crossover, Partial Replicate, Oral BE Pivotal Study of SYN010 HFA 160/4.5 Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block
The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA Inhaler and Symbicort 160/4.5μg in healthy volunteers without charcoal block.
Read the detailed description
A pivotal, single-dose, randomized, open-label, partial replicate, three-period, three-sequence, two-treatment, three-way crossover, comparative bioavailability study.
Ninety-nine, male and female volunteers, 20-45 years of age, with a body mass index (BMI) within 18.5-30.0 kg/m2, inclusive, will be enrolled. (The body weight should be over 50 kg, inclusive, respectively)
A single dose of 8 puffs (eq. to budesonide 1280 μg /formoterol fumarate dihydrate 36 μg) in each study period.
- Being tested
- Budesonide, Formoterol
- 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.
BudesonideDrug
Inhaled corticosteroid
FormoterolDrug
Long Acting Beta Agonist (LABA)
| Study group | Role | What they receive |
|---|---|---|
| Reference 1 Symbicort Inhaler 160/4.5μg | Active comparator | Reference 1: Symbicort Inhaler (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs Receives: Drug: Budesonide; Drug: Formoterol |
| SYN010 HFA Inhaler | Experimental | SYN010 HFA (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs Receives: Drug: Budesonide; Drug: Formoterol |
| Reference 2 Symbicort Inhaler 160/4.5μg | Active comparator | Reference 2: Symbicort Inhaler (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs Receives: Drug: Budesonide; Drug: Formoterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
Measured: Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.
Maximum plasma concentration (Cmax)
Measured: Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.
Secondary outcomes (4)
Time to reach Maximum plasma concentration (Tmax)
Measured: Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.
Blood pressure (BP)
Measured: Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.
Body temperature (BT)
Measured: Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.
Pulse rate (PR)
Measured: Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start19 Jun 2017
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intech Biopharm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen-Kuei Chang, M.D., Principal investigator, Clinical Pharmacology Unit of Mackay Memorial Hospital Tamshui Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494321
- Sponsor's protocol ID
- MCPE15003M4
- Status last verified
- Feb 2018
- First submitted
- 28 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Open-Label, Two-Treatment, Three-Period, Three-Sequence, Three-Way Crossover, Partial Replicate, Oral BE Pivotal Study of SYN010 HFA 160/4.5 Inhaler and Symbicort® 160/4.5 in Healthy Volunteers Without Charcoal Block
- ClinicalTrials.gov ID
- NCT04494321
- Acronym / sponsor ID
- MCPE15003M4
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Intech Biopharm Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 31 Jul 2020 (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.
The objective of this pivotal study is to evaluate the relative bioavailability of SYN010 HFA Inhaler and Symbicort 160/4.5μg in healthy volunteers without charcoal block.
Detailed description
A pivotal, single-dose, randomized, open-label, partial replicate, three-period, three-sequence, two-treatment, three-way crossover, comparative bioavailability study.
Ninety-nine, male and female volunteers, 20-45 years of age, with a body mass index (BMI) within 18.5-30.0 kg/m2, inclusive, will be enrolled. (The body weight should be over 50 kg, inclusive, respectively)
A single dose of 8 puffs (eq. to budesonide 1280 μg /formoterol fumarate dihydrate 36 μg) in each study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reference 1 Symbicort Inhaler 160/4.5μg | Active comparator | Drug: Budesonide, Drug: FormoterolReference 1: Symbicort Inhaler (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs |
| SYN010 HFA Inhaler | Experimental | Drug: Budesonide, Drug: FormoterolSYN010 HFA (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs |
| Reference 2 Symbicort Inhaler 160/4.5μg | Active comparator | Drug: Budesonide, Drug: FormoterolReference 2: Symbicort Inhaler (Budesonide/ Formoterol, 160/4.5μg), Single dose, 8 puffs |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy male and female volunteers, aged 20-45, inclusive.
- BMI that is within 18.5-30.0 kg/m², inclusive. (The body weight should be over 50 kg, inclusive, respectively)
- Healthy or Non Clinical Significant, according to the medical history, Electrocardiography (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°C.
- Clinical laboratory values within reference range or Non-Clinical Significance (NCS) judged by the Principal Investigator/Sub-Investigator.
Key exclusion criteria (27 listed)
- 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: Human immunodeficiency virus (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.
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 |
|---|---|---|
| BudesonideInhaled corticosteroid | Drug | Reference 1 Symbicort Inhaler 160/4.5μg, Reference 2 Symbicort Inhaler 160/4.5μg, SYN010 HFA Inhaler |
| FormoterolLong Acting Beta Agonist (LABA) | Drug | Reference 1 Symbicort Inhaler 160/4.5μg, Reference 2 Symbicort Inhaler 160/4.5μg, SYN010 HFA Inhaler |
Primary outcome
Area Under Curve (AUC)
Time frame: Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.
Maximum plasma concentration (Cmax)
Time frame: Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.
4 secondary outcomes
Time to reach Maximum plasma concentration (Tmax)
Time frame: Pre-dose and at 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 hours after dosing.
Blood pressure (BP)
Time frame: Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.
Body temperature (BT)
Time frame: Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.
Pulse rate (PR)
Time frame: Pre-dose and at 0.5, 16, 24 and 36 hours after dosing.
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 31 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Wen-Kuei Chang, M.D. principal investigator
Clinical Pharmacology Unit of Mackay Memorial Hospital Tamshui Branch
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 Budesonide and Formoterol in people with Asthma and 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 31 Jul 2020. 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 0.03, 0.08, 0.17, 0.25, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 9, 12, 16, 24 and 36 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?
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 31 Jul 2020.