Pharmacokinetics and Bioequivalence Study of Budesonide Inhalation Aerosol in Humans

NCT06924190 | Completed

• 1 other identifier: BT-BDND-IA-BE01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The test formulation of Budesonide Inhalation Aerosol is bioequivalent to the reference formulation in healthy Chinese subjects under fasting conditions.

Conditions

Bioequivalence Study in Healthy Subjects

Keywords

Budesonide Inhalation Aerosol

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  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

  12 days

• Area under the plasma concentration versus time curve (AUC)0-∞

  area under the plasma concentration-time curve from zero to infinity

  12 days

Other Outcomes (5)

• maximum plasma concentration (tmax)

  12 days

• Incidence of Treatment-Emergent Adverse Events

  During 12 days

• Incidence of abnormal blood pressure

  During 12 days

Study Arms (2)

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.

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.

Drug: budesonide 200ug/puff inhalation aerosol

Interventions

Budiair® 200ug/puff inhalation aerosol DRUG

The subjects randomly received one puff Budiair®(budesonide inhalation aerosol 200ug/puff )

Also known as: Budiair®

Reference Group [Budiair® 200ug/puff ( budesonide inhalation aerosol )]

budesonide 200ug/puff inhalation aerosol DRUG

The subjects randomly received one puff budesonide inhalation aerosol(200ug/puff )

Test Group [200ug/puff (budesonide inhalation aerosol)]

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Chinese male or female subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*\*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.

You may not qualify if:

• \*\*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.).
• \*\*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.

Sponsors & Collaborators

• Lunan Better Pharmaceutical Co., LTD.: lead
• Wuxi People's Hospital: collaborator

Study Sites (2)

Wuxi People's Hospital

Wuxi, Jiangsu, 214000, China

Location

Lunan Better Pharmaceutical Co., Ltd.

Linyi, Shandong, 276002, China

Location

Related Publications (1)

• 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.

  PMID: 41318994 DERIVED

MeSH Terms

Interventions

Budesonide

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kai Huang, Dr

  Wuxi People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 11, 2025
• Study Start: December 30, 2024
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)