Bioequivalence Study of Budesonide/Formoterol Inhalation Powder in Healthy Participants

NCT07804303 | Completed Phase 1

• 2 other identifiers: SHXHH-BDF-DPI-BE-02CTR20240076
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Asthma; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Budesonide, Formoterol Fumarate Drug Combination; Therapeutic Equivalency; Pharmacokinetics; Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Concentration (Cmax)

  Cmax is the peak plasma concentration of budesonide and formoterol, obtained directly from the plasma concentration-time data.

  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.

  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.

  0 to 36 hours post-dose in each period

Secondary Outcomes (6)

• Time to Maximum Observed Concentration (Tmax)

  0 to 36 hours post-dose in each period

• Terminal Elimination Rate Constant (λz)

  0 to 36 hours post-dose in each period

• Terminal Elimination Half-Life (t1/2)

  0 to 36 hours post-dose in each period

• Percentage of AUC0-∞ Extrapolated (AUC_%Extrap)

  0 to 36 hours post-dose in each period

• Number of Participants with Adverse Events (AEs)

  From first dose administration until follow-up visit (approximately 3 days after the last dose in Period II)

Study Arms (2)

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.

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.

Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test); Drug: Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference)

Interventions

Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Test) DRUG

160 μg/4.5 μg, administered as 2 inhalations, manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd.

Also known as: Pingchuan®

R-T Sequence; T-R Sequence

Budesonide and Formoterol Fumarate Powder for Inhalation (II) (Reference) DRUG

160 μg/4.5 μg, administered as 2 inhalations, manufactured by AstraZeneca AB.

Also known as: Symbicort® Turbuhaler®

R-T Sequence; T-R Sequence

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Shanghai Xin Huanghe Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Nanjing Gaoxin Hospital

Nanjing, Jiangsu, 210031, China

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Inhalation; pingchuan yiqi

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-label study. Participants, investigators, care providers, and clinical staff are aware of treatment assignments. However, bioanalytical analysts who perform pharmacokinetic sample analysis are masked to treatment assignments. Plasma concentrations of budesonide and formoterol are determined using HPLC-MS/MS. Analytical testing personnel do not have access to the randomization code during sample analysis. The blind is maintained until the final bioanalytical report is issued and the database is locked. Data management and statistical personnel are not masked.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: January 13, 2024
• Primary Completion: January 22, 2024
• Study Completion: January 24, 2024
• Last Updated: September 4, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)