Bioequivalence Study in Healthy SubjectsNCT06924190
Pharmacokinetics and Bioequivalence Study of Budesonide Inhalation Aerosol in Humans
A study testing Budiair® 200ug/puff inhalation aerosol and budesonide 200ug/puff inhalation aerosol in people with Bioequivalence Study in Healthy Subjects, run by Lunan Better Pharmaceutical Co., LTD. at 2 sites in China.
Trial summary
The test formulation of Budesonide Inhalation Aerosol is bioequivalent to the reference formulation in healthy Chinese subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence Study in Healthy Subjects
- What is being tested?
- Budiair® 200ug/puff inhalation aerosol and budesonide 200ug/puff inhalation aerosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesChina
- Study dates
- 30 Dec 2024to 20 Jan 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: Chinese male or female subjects aged 18 to 65 years (inclusive of the boundary values).
- Weight: Males must weigh ≥50.0 kg, and females must weigh ≥45.0 kg. The Body Mass Index (BMI) calculated as \[ \text{BMI} = \frac{\text{weight (kg)}}{\text{height}^2 (\text{m}^2)} \] must be between 19.0 and 26.0 kg/m² (inclusive of the boundary values).
- Informed Consent: Subjects must fully understand the purpose, nature, methods, and potential adverse reactions of the trial and voluntarily sign a written informed consent form.
- Communication and Compliance: Subjects must be able to communicate effectively with the investigator, correctly use the inhaler device after training, and understand and comply with all the requirements of the study.
Who cannot join
- Examination: Subjects with clinically significant abnormalities in physical examination, vital signs, ECG, chest X-ray, complete blood count, urinalysis, or biochemical blood tests; subjects with serum potassium levels below the lower limit of normal.
- Examination: Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus antigen and antibody (HIV), or syphilis antibody.
- Examination: Subjects with a measured FEV1/predicted FEV1 ≤ 80% or FVC ≤ 80% of the predicted value in pulmonary function tests; or subjects whose pulmonary function test results are judged by the investigator to indicate small airway disease.
- Inquiry: Subjects with a history or current diagnosis of chronic or severe diseases of the liver, kidneys, endocrine system, urinary system, digestive system, blood, or lymphatic system.
- Inquiry: Subjects with a history or current diagnosis of chronic or severe respiratory diseases.
- Inquiry: Subjects with a history or current diagnosis of chronic or severe cardiovascular diseases (especially ischemic heart disease, hypertension, aneurysm, paroxysmal tachycardia, etc.).
Show all 29Show fewer
- Inquiry: Subjects with a history or current diagnosis of chronic or severe nervous system diseases; or subjects with a history of frequent headaches or dizziness, or those who have experienced headaches or dizziness within one week before screening.
- Inquiry: Subjects with a history of allergy to budesonide, its excipients, or other corticosteroid components; or subjects with a known history of allergies to two or more food or environmental substances, or a history of atopic allergic diseases (urticaria, rash, eczematous dermatitis, etc.).
- Inquiry: Subjects with a history or current diagnosis of glaucoma, cataracts, or blurred vision.
- Examination: Subjects with current oral ulcers, pharyngitis, or enlarged tonsils.
- Inquiry: Subjects who consumed excessive amounts of tea, coffee, or caffeine-containing beverages (8 cups or more per day, 1 cup = 250 mL) within three months before screening, or those who do not agree to abstain from these beverages during the trial.
- Inquiry: Subjects who consumed food that may affect drug metabolism (including grapefruit or grapefruit products, dragon fruit, mango, pomelo, etc.) within 48 hours before screening, or those who do not agree to abstain from such food during the trial.
- Inquiry: Subjects with special dietary requirements that prevent adherence to a uniform diet, or those with difficulty swallowing.
- Inquiry + Examination: Subjects who cannot tolerate venipuncture or have a history of fainting due to blood or needles, or those with difficulty in blood collection.
- Inquiry: Subjects who have undergone surgery that the investigator judges may affect drug absorption, distribution, metabolism, or excretion; or those who plan to undergo surgery within four weeks before screening or during the trial.
- Inquiry: Subjects who used any medication (prescription drugs, over-the-counter drugs, health supplements, vaccines, herbal medicines, etc.) within 30 days before screening.
- Examination: Subjects with a positive alcohol breath test result (breath alcohol content > 0.0 mg/100 mL).
- Inquiry: Subjects with a history of alcohol abuse within the past year (consuming ≥14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine) or those who cannot abstain from alcohol during the trial.
- Inquiry: Subjects who smoked ≥5 cigarettes per day within three months before screening or those who cannot quit smoking during the trial.
- Examination: Subjects with a positive urine nicotine test result.
- Inquiry + Internet Screening: Subjects who participated in any drug clinical trial within three months before screening and received medication, or those who plan to participate in other clinical trials during this study.
- Inquiry: Subjects who donated blood or had significant bleeding (more than 400 mL) within three months before screening; or those who plan to donate blood or blood components during the study or within three months after the study ends.
- Examination: Subjects with a positive urine drug abuse screening result.
- Inquiry: Subjects with a history of drug abuse within the past five years.
- Inquiry + Examination: Pregnant or breastfeeding women, or women of childbearing age who had unprotected sexual intercourse with their partners within 14 days before screening.
- Inquiry: Female subjects who used long-acting estrogen or progesterone injections or implants within six months before screening.
- Inquiry: Male subjects (or their partners) or female subjects who plan to conceive or donate sperm or eggs during the entire trial period and within three months after the study ends, and are unwilling to take appropriate contraceptive measures.
- Subjects with poor compliance.
- Subjects who may not be able to complete the study for other reasons, or those whom the investigator deems unsuitable for enrollment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Lunan Better Pharmaceutical Co., Ltd.
Linyi, Shandong, 276002
Wuxi People's Hospital
Wuxi, Jiangsu, 214000
About this study
Official title: Clinical Equivalency Study of Two Formulations of Budesonide Inhalation Aerosol
The test formulation of Budesonide Inhalation Aerosol is bioequivalent to the reference formulation in healthy Chinese subjects under fasting conditions.
Read the detailed description
In a four-period single-dose oropharyngeal inhalation study of the investigational drug, with a washout period of 3 days. After dosing, subjects should thoroughly rinse their mouth with 150 ml of water and spit out the rinse water.
Blood plasma concentrations of budesonide are collected within the specified sampling time for pharmacokinetic parameter analysis. In each period, blood samples are collected at pre-dose 0 h and at 0.03, 0.07, 0.10, 0.13, 0.17, 0.20, 0.25, 0.33, 0.42, 0.50, 0.75, 1, 2, 4, 6, 8, 10, 12, and 16 h post-dose.
- Conditions
- Bioequivalence Study in Healthy Subjects
- Being tested
- Budiair® 200ug/puff inhalation aerosol, budesonide 200ug/puff inhalation aerosol
- Keywords
- Budesonide Inhalation Aerosol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budiair® 200ug/puff inhalation aerosolDrug
Also called Budiair®
The subjects randomly received one puff Budiair®(budesonide inhalation aerosol 200ug/puff )
budesonide 200ug/puff inhalation aerosolDrug
The subjects randomly received one puff budesonide inhalation aerosol(200ug/puff )
| Study group | Role | What they receive |
|---|---|---|
| Reference Group [Budiair® 200ug/puff ( budesonide inhalation aerosol )] | Active comparator | After being trained and qualified, the subjects strictly administered one puff （Budiair®，200ug/puff ）of the investigational drug under the supervision of the investigator in accordance with the SOP for drug administration. After taking the medication, the subjects thoroughly rinsed their mouths multiple times with 150 mL of water and then spat out the mouthwash. Receives: Drug: Budiair® 200ug/puff inhalation aerosol |
| Test Group [200ug/puff (budesonide inhalation aerosol)] | Experimental | After being trained and qualified, the subjects strictly administered one puff （budesonide inhalation aerosol，200ug/puff ）of the investigational drug under the supervision of the investigator in accordance with the SOP for drug administration. After taking the medication, the subjects thoroughly rinsed their mouths multiple times with 150 mL of water and then spat out the mouthwash. Receives: Drug: budesonide 200ug/puff inhalation aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Measured: 12 days
Area under the plasma concentration versus time curve (AUC) 0-t
plasma concentration-time curve from zero to the time of the last measurable time point t
Measured: 12 days
Area under the plasma concentration versus time curve (AUC)0-∞
area under the plasma concentration-time curve from zero to infinity
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start30 Dec 2024
- Primary completion20 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bioequivalence Study in Healthy SubjectsStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lunan Better Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wuxi People's Hospital
- Responsible party
- Sponsor
- Investigators
- Kai Huang, Dr, Principal investigator, Wuxi People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924190
- Sponsor's protocol ID
- BT-BDND-IA-BE01
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang K, Yin S, Huang W, Ding L, Qin W, Qian Z, Ding Y, Que L, Shi Y, Gao J, Zhao Y. A Single Dose, Randomized, Open-Label, Cross-Over Bioequivalence Study of Budesonide Pressurized Metered-Dose Inhaler in Healthy Chinese Subjects. Pharmacol Res Perspect. 2025 Dec;13(6):e70197. doi: 10.1002/prp2.70197.
PubMed 41318994
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Equivalency Study of Two Formulations of Budesonide Inhalation Aerosol
- ClinicalTrials.gov ID
- NCT06924190
- Acronym / sponsor ID
- BT-BDND-IA-BE01
- Conditions
- Bioequivalence Study in Healthy Subjects
- Keywords
- Budesonide Inhalation Aerosol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Lunan Better Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Wuxi People's Hospital
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 11 Apr 2025 (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 test formulation of Budesonide Inhalation Aerosol is bioequivalent to the reference formulation in healthy Chinese subjects under fasting conditions.
Detailed description
In a four-period single-dose oropharyngeal inhalation study of the investigational drug, with a washout period of 3 days. After dosing, subjects should thoroughly rinse their mouth with 150 ml of water and spit out the rinse water.
Blood plasma concentrations of budesonide are collected within the specified sampling time for pharmacokinetic parameter analysis. In each period, blood samples are collected at pre-dose 0 h and at 0.03, 0.07, 0.10, 0.13, 0.17, 0.20, 0.25, 0.33, 0.42, 0.50, 0.75, 1, 2, 4, 6, 8, 10, 12, and 16 h post-dose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference Group [Budiair® 200ug/puff ( budesonide inhalation aerosol )] | Active comparator | Drug: Budiair® 200ug/puff inhalation aerosolAfter being trained and qualified, the subjects strictly administered one puff （Budiair®，200ug/puff ）of the investigational drug under the supervision of the investigator in accordance with the SOP for drug administration. After taking the medication, the subjects thoroughly rinsed their mouths multiple times with 150 mL of water and then spat out the mouthwash. |
| Test Group [200ug/puff (budesonide inhalation aerosol)] | Experimental | Drug: budesonide 200ug/puff inhalation aerosolAfter being trained and qualified, the subjects strictly administered one puff （budesonide inhalation aerosol，200ug/puff ）of the investigational drug under the supervision of the investigator in accordance with the SOP for drug administration. After taking the medication, the subjects thoroughly rinsed their mouths multiple times with 150 mL of water and then spat out the mouthwash. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: Chinese male or female subjects aged 18 to 65 years (inclusive of the boundary values).
- Weight: Males must weigh ≥50.0 kg, and females must weigh ≥45.0 kg. The Body Mass Index (BMI) calculated as \[ \text{BMI} = \frac{\text{weight (kg)}}{\text{height}^2 (\text{m}^2)} \] must be between 19.0 and 26.0 kg/m² (inclusive of the boundary values).
- Informed Consent: Subjects must fully understand the purpose, nature, methods, and potential adverse reactions of the trial and voluntarily sign a written informed consent form.
- Communication and Compliance: Subjects must be able to communicate effectively with the investigator, correctly use the inhaler device after training, and understand and comply with all the requirements of the study.
Key exclusion criteria (29 listed)
- Examination: Subjects with clinically significant abnormalities in physical examination, vital signs, ECG, chest X-ray, complete blood count, urinalysis, or biochemical blood tests; subjects with serum potassium levels below the lower limit of normal.
- Examination: Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV), human immunodeficiency virus antigen and antibody (HIV), or syphilis antibody.
- Examination: Subjects with a measured FEV1/predicted FEV1 ≤ 80% or FVC ≤ 80% of the predicted value in pulmonary function tests; or subjects whose pulmonary function test results are judged by the investigator to indicate small airway disease.
- Inquiry: Subjects with a history or current diagnosis of chronic or severe diseases of the liver, kidneys, endocrine system, urinary system, digestive system, blood, or lymphatic system.
- Inquiry: Subjects with a history or current diagnosis of chronic or severe respiratory diseases.
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 |
|---|---|---|
| Budiair® 200ug/puff inhalation aerosolAlso: Budiair®The subjects randomly received one puff Budiair®(budesonide inhalation aerosol 200ug/puff ) | Drug | Reference Group [Budiair® 200ug/puff ( budesonide inhalation aerosol )] |
| budesonide 200ug/puff inhalation aerosolThe subjects randomly received one puff budesonide inhalation aerosol(200ug/puff ) | Drug | Test Group [200ug/puff (budesonide inhalation aerosol)] |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 12 days
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 0-t
Time frame: 12 days
plasma concentration-time curve from zero to the time of the last measurable time point t
Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 12 days
area under the plasma concentration-time curve from zero to infinity
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 11 Apr 2025.
- Derived from this study: PubMed 41318994Huang K, Yin S, Huang W, Ding L, Qin W, Qian Z, Ding Y, Que L, Shi Y, Gao J, Zhao Y. A Single Dose, Randomized, Open-Label, Cross-Over Bioequivalence Study of Budesonide Pressurized Metered-Dose Inhaler in Healthy Chinese Subjects. Pharmacol Res Perspect. 2025 Dec;13(6):e70197. doi: 10.1002/prp2.70197.
- 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.
Kai Huang, Dr principal investigator
Wuxi People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budiair® 200ug/puff inhalation aerosol and budesonide 200ug/puff inhalation aerosol in people with Bioequivalence Study in Healthy Subjects, run by Lunan Better Pharmaceutical Co., LTD. at 2 sites 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 29 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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Peak Plasma Concentration (Cmax) (time frame: 12 days). 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?
On the ClinicalTrials.gov record for NCT06924190, which also lists 1 linked publication.
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 11 Apr 2025.