AsthmaPhase 1BF-BENCT07804303
Bioequivalence Study of Budesonide/Formoterol Inhalation Powder in Healthy Participants
A Phase 1 study testing Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test) and Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference) in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The goal of this study is to learn if a new formulation of Budesonide/Formoterol Inhalation Powder (160μg/4.5μg), manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd., works the same as the already approved reference product, Symbicort® Turbuhaler® (160μg/4.5μg), in the body. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test) and Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2024to 24 Jan 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 45 years (inclusive), both males and females.
- Female subjects weighing ≥45.0 kg and male subjects weighing ≥50.0 kg, with a body mass index (BMI) between 18.5 and 26.0 kg/m² (inclusive) (BMI = body weight kg / height m²).
- Subjects agree to have no fertility or sperm/egg donation plans during the study and within 60 days after study completion, and voluntarily adopt one or more non-pharmacological contraceptive measures during the trial (e.g., complete abstinence, contraceptive ring, partner sterilization, etc.).
- Voluntarily participate in this clinical trial, able to communicate well with the investigator, and have signed written informed consent.
Who cannot join
- Known allergy to the study drug (including its excipients) or its analogues, or allergic constitution (allergic to two or more drugs, foods, or pollen), or known allergy to corticosteroid anti-inflammatory drugs.
- History of respiratory diseases (active or inactive tuberculosis, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, asthma, chronic cough), immune system diseases, cardiovascular diseases, renal diseases, or hepatic diseases.
- Previous or current mental disorders, such as schizophrenia, delusional disorder, panic disorder, obsessive-compulsive disorder, behavioral volitional disorder, postpartum mental disorder, paranoid mental disorder, and various neuropsychiatric diseases associated with organic lesions, including but not limited to Alzheimer's disease, convulsions, epileptic seizures, suicidal tendencies, etc.
- Previous or current glaucoma.
- Respiratory tract infection within 1 month (30 days) prior to the trial; history of bronchospasm.
- Use of any medication within 1 month (30 days) prior to the trial, including vitamins, herbal medicines, and drugs that inhibit or induce CYP3A4 enzyme activity (e.g., inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors: SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines).
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- Major surgery within 3 months (90 days) prior to the trial, or surgery that may significantly affect the in vivo process of the study drug or safety evaluation.
- Use of an investigational drug within 3 months (90 days) prior to the trial, or plan to participate in other clinical trials during this study.
- Blood loss/blood donation exceeding 400 mL within 3 months (90 days) prior to the trial (excluding physiological blood loss in females), receipt of blood transfusion or blood products, or plan to donate blood during the trial or within 1 month (30 days) after the trial.
- Excessive daily consumption of tea, coffee, or caffeinated beverages within 1 month (30 days) prior to the trial (average >8 cups per day, 200 mL per cup).
- Consumption of any beverages or foods rich in grapefruit or xanthine within 48 hours prior to dosing; consumption of other substances affecting CYP3A4 enzyme metabolism within 48 hours prior to dosing (e.g., grapefruit, starfruit, dragon fruit, etc.).
- Smoking history within 1 year prior to the trial, or no smoking history within 1 year but previous smoking duration >3 years, or positive nicotine test result.
- Any history of drug dependence, or positive urine drug screening result.
- Frequent alcohol consumption within 3 months (90 days) prior to the trial (≥3 times per week, with an average of ≥200 mL of 50° liquor equivalent per session) or inability to abstain from alcohol during the trial.
- Positive results for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody at screening.
- Physical examination, vital signs, laboratory tests, 12-lead ECG, or chest X-ray/CT findings at screening judged by the clinician as clinically significant abnormalities.
- Pulmonary function test: FEV₁ measured/FEV₁ predicted ≤80% or FVC ≤80% of predicted value.
- Subjects who appear nervous during screening training with the inspiratory flow meter, or who cannot meet the inspiratory flow meter operation requirements after training.
- Pregnant or lactating women, or positive pregnancy test.
- Poor forearm venous conditions, difficulty in blood collection, or inability to tolerate venipuncture.
- Special dietary requirements, or inability to comply with a unified diet, resulting in inability to complete the trial.
- Other conditions deemed by the investigator as reasons for exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Crossover Bioequivalence Study of Budesonide/Formoterol Inhalation Powder in Healthy Participants Under Fasting Conditions
The goal of this study is to learn if a new formulation of Budesonide/Formoterol Inhalation Powder (160μg/4.5μg), manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd., works the same as the already approved reference product, Symbicort® Turbuhaler® (160μg/4.5μg), in the body. It will also learn about the safety of the new formulation.
The main questions it aims to answer are:
Read more
- How quickly and how much of the study drug gets into the blood after inhalation, compared with the reference product?
- What medical problems do participants have when taking the study drug?
Researchers will compare the new formulation to the reference product (the already approved treatment) to see if they are bioequivalent.
Participants will:
- Be randomly assigned to receive either the new formulation or the reference product in the first period, then switch to the other in the second period
- Take a single dose of 2 inhalations in each period, with a 4-day washout period between doses
- Have 22 blood samples collected over 36 hours after each dose to measure drug levels in the blood
- Visit the clinic for checkups, including vital signs, physical examinations, and laboratory tests
- Be monitored for any side effects throughout the study
- Being tested
- Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test), Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)
- Keywords
- Budesonide, Formoterol Fumarate Drug Combination, Therapeutic Equivalency, Pharmacokinetics, Healthy Volunteers
- 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.
Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test)Drug
Also called Pingchuan®
160 μg/4.5 μg, administered as 2 inhalations, manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd.
Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)Drug
Also called Symbicort® Turbuhaler®
160 μg/4.5 μg, administered as 2 inhalations, manufactured by AstraZeneca AB.
| Study group | Role | What they receive |
|---|---|---|
| T-R Sequence | Experimental | Participants in this arm will receive a single dose of the Test Formulation (Budesonide and Formoterol Fumarate Powder for Inhalation (II), 160 μg/4.5 μg) in Period 1, followed by a single dose of the Reference Formulation (Symbicort® Turbuhaler®, 160 μg/4.5 μg) in Period 2, with a 4-day washout period between doses. Receives: Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test); Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference) |
| R-T Sequence | Experimental | Participants in this arm will receive a single dose of the Reference Formulation (Symbicort® Turbuhaler®, 160 μg/4.5 μg) in Period 1, followed by a single dose of the Test Formulation (Budesonide and Formoterol Fumarate Powder for Inhalation (II), 160 μg/4.5 μg) in Period 2, with a 4-day washout period between doses. Receives: Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test); Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax)
Cmax is the peak plasma concentration of budesonide and formoterol, obtained directly from the plasma concentration-time data.
Measured: 0 to 36 hours post-dose in each period
Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
AUC0-t is calculated using the linear trapezoidal rule from time 0 to the time of the last measurable concentration.
Measured: 0 to 36 hours post-dose in each period
Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
AUC0-∞ is calculated as AUC0-t + Ct/λz, where Ct is the last measurable concentration and λz is the terminal elimination rate constant.
Measured: 0 to 36 hours post-dose in each period
Secondary outcomes (6)
Time to Maximum Observed Concentration (Tmax)
Tmax is the time to reach peak plasma concentration, obtained directly from the plasma concentration-time data.
Measured: 0 to 36 hours post-dose in each period
Terminal Elimination Rate Constant (λz)
λz is the terminal elimination rate constant, calculated using linear regression of the terminal phase of the semi-logarithmic concentration-time curve.
Measured: 0 to 36 hours post-dose in each period
Terminal Elimination Half-Life (t1/2)
t1/2 is the terminal elimination half-life, calculated as ln2/λz.
Measured: 0 to 36 hours post-dose in each period
Percentage of AUC0-∞ Extrapolated (AUC_%Extrap)
AUC_%Extrap is calculated as [(AUC0-∞ - AUC0-t) / AUC0-∞] × 100%.
Measured: 0 to 36 hours post-dose in each period
Number of Participants with Adverse Events (AEs)
Adverse events are recorded and graded according to NCI-CTCAE version 5.0.
Measured: From first dose administration until follow-up visit (approximately 3 days after the last dose in Period II)
Number of Participants with Serious Adverse Events (SAEs)
Serious adverse events are recorded according to NCI-CTCAE version 5.0 criteria.
Measured: From first dose administration until follow-up visit (approximately 3 days after the last dose in Period II)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start13 Jan 2024
- Primary completion22 Jan 2024
- Study completion24 Jan 2024
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
- Model description
- Subjects will be randomized into one of two treatment sequences: Test formulation (T) followed by Reference formulation (R), or R followed by T. Each subject will receive a single dose of 2 inhalations in each period, with a 4-day washout period between the two periods.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Xin Huanghe Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804303
- Sponsor's protocol ID
- SHXHH-BDF-DPI-BE-02
- Other IDs
- CTR20240076
- Acronym
- BF-BE
- Status last verified
- Jun 2025
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The informed consent obtained from participants in this study did not include provisions for the sharing of individual participant data with third parties or for the transfer of data outside of China. Sharing IPD would therefore be inconsistent with the scope of the consent provided by participants and with applicable data protection requirements. Requests for the study protocol and statistical analysis plan may be directed to the sponsor at clinicalmedicine@chenpon.com and will be considered on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Bioequivalence Study of Budesonide/Formoterol Inhalation Powder in Healthy Participants Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT07804303
- Acronym / sponsor ID
- BF-BE / SHXHH-BDF-DPI-BE-02
- Keywords
- Budesonide, Formoterol Fumarate Drug Combination, Therapeutic Equivalency, Pharmacokinetics, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Xin Huanghe Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 4 Sep 2026 (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 goal of this study is to learn if a new formulation of Budesonide/Formoterol Inhalation Powder (160μg/4.5μg), manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd., works the same as the already approved reference product, Symbicort® Turbuhaler® (160μg/4.5μg), in the body. It will also learn about the safety of the new formulation.
The main questions it aims to answer are:
- How quickly and how much of the study drug gets into the blood after inhalation, compared with the reference product?
- What medical problems do participants have when taking the study drug?
Researchers will compare the new formulation to the reference product (the already approved treatment) to see if they are bioequivalent.
Participants will:
- Be randomly assigned to receive either the new formulation or the reference product in the first period, then switch to the other in the second period
- Take a single dose of 2 inhalations in each period, with a 4-day washout period between doses
- Have 22 blood samples collected over 36 hours after each dose to measure drug levels in the blood
- Visit the clinic for checkups, including vital signs, physical examinations, and laboratory tests
- Be monitored for any side effects throughout the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized into one of two treatment sequences: Test formulation (T) followed by Reference formulation (R), or R followed by T. Each subject will receive a single dose of 2 inhalations in each period, with a 4-day washout period between the two periods.
| Arm | Type | Receives |
|---|---|---|
| T-R Sequence | Experimental | Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test), Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)Participants in this arm will receive a single dose of the Test Formulation (Budesonide and Formoterol Fumarate Powder for Inhalation (II), 160 μg/4.5 μg) in Period 1, followed by a single dose of the Reference Formulation (Symbicort® Turbuhaler®, 160 μg/4.5 μg) in Period 2, with a 4-day washout period between doses. |
| R-T Sequence | Experimental | Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test), Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)Participants in this arm will receive a single dose of the Reference Formulation (Symbicort® Turbuhaler®, 160 μg/4.5 μg) in Period 1, followed by a single dose of the Test Formulation (Budesonide and Formoterol Fumarate Powder for Inhalation (II), 160 μg/4.5 μg) in Period 2, with a 4-day washout period between doses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 45 years (inclusive), both males and females.
- Female subjects weighing ≥45.0 kg and male subjects weighing ≥50.0 kg, with a body mass index (BMI) between 18.5 and 26.0 kg/m² (inclusive) (BMI = body weight kg / height m²).
- Subjects agree to have no fertility or sperm/egg donation plans during the study and within 60 days after study completion, and voluntarily adopt one or more non-pharmacological contraceptive measures during the trial (e.g., complete abstinence, contraceptive ring, partner sterilization, etc.).
- Voluntarily participate in this clinical trial, able to communicate well with the investigator, and have signed written informed consent.
Key exclusion criteria (22 listed)
- Known allergy to the study drug (including its excipients) or its analogues, or allergic constitution (allergic to two or more drugs, foods, or pollen), or known allergy to corticosteroid anti-inflammatory drugs.
- History of respiratory diseases (active or inactive tuberculosis, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, asthma, chronic cough), immune system diseases, cardiovascular diseases, renal diseases, or hepatic diseases.
- Previous or current mental disorders, such as schizophrenia, delusional disorder, panic disorder, obsessive-compulsive disorder, behavioral volitional disorder, postpartum mental disorder, paranoid mental disorder, and various neuropsychiatric diseases associated with organic lesions, including but not limited to Alzheimer's disease, convulsions, epileptic seizures, suicidal tendencies, etc.
- Previous or current glaucoma.
- Respiratory tract infection within 1 month (30 days) prior to the trial; history of bronchospasm.
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 |
|---|---|---|
| Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test)Also: Pingchuan®160 μg/4.5 μg, administered as 2 inhalations, manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd. | Drug | R-T Sequence, T-R Sequence |
| Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)Also: Symbicort® Turbuhaler®160 μg/4.5 μg, administered as 2 inhalations, manufactured by AstraZeneca AB. | Drug | R-T Sequence, T-R Sequence |
Primary outcome
Maximum Observed Concentration (Cmax)
Time frame: 0 to 36 hours post-dose in each period
Cmax is the peak plasma concentration of budesonide and formoterol, obtained directly from the plasma concentration-time data.
Area Under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
Time frame: 0 to 36 hours post-dose in each period
AUC0-t is calculated using the linear trapezoidal rule from time 0 to the time of the last measurable concentration.
Area Under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-∞)
Time frame: 0 to 36 hours post-dose in each period
AUC0-∞ is calculated as AUC0-t + Ct/λz, where Ct is the last measurable concentration and λz is the terminal elimination rate constant.
6 secondary outcomes
Time to Maximum Observed Concentration (Tmax)
Time frame: 0 to 36 hours post-dose in each period
Terminal Elimination Rate Constant (λz)
Time frame: 0 to 36 hours post-dose in each period
Terminal Elimination Half-Life (t1/2)
Time frame: 0 to 36 hours post-dose in each period
Percentage of AUC0-∞ Extrapolated (AUC_%Extrap)
Time frame: 0 to 36 hours post-dose in each period
Number of Participants with Adverse Events (AEs)
Time frame: From first dose administration until follow-up visit (approximately 3 days after the last dose in Period II)
Number of Participants with Serious Adverse Events (SAEs)
Time frame: From first dose administration until follow-up visit (approximately 3 days after the last dose in Period II)
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 4 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The informed consent obtained from participants in this study did not include provisions for the sharing of individual participant data with third parties or for the transfer of data outside of China. Sharing IPD would therefore be inconsistent with the scope of the consent provided by participants and with applicable data protection requirements. Requests for the study protocol and statistical analysis plan may be directed to the sponsor at clinicalmedicine@chenpon.com and will be considered on a case-by-case basis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fumarate Powder for Inhalation (II) (Test) and Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference) in people with Asthma and Chronic Obstructive Pulmonary Disease (COPD), run by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. at 1 site in China.
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 4 inclusion and 22 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 4 Sep 2026. 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 China. 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?
Maximum Observed Concentration (Cmax) (time frame: 0 to 36 hours post-dose in each period). The study lists 3 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 4 Sep 2026.