A Food-Effect Study of Budesonide Delayed Release Tablet (D23A) in Healthy Chinese Participants

Prior treatment

• History of chronic or serious diseases of the cardiovascular, hepatic, renal, biliary, respiratory, hematologic and lymphatic, endocrine, immune, psychiatric, neuromuscular, or gastrointestinal systems within one year prior to screening until randomization;
• History of gastrointestinal diseases (including current) from one year prior to screening until randomization, including chronic or active upper gastrointestinal diseases such as esophageal disorder, gastritis, duodenitis, ulcer, or active gastrointestinal hemorrhage or gastrointestinal surgery;
• Have had or currently have infectious diseases within 1 month prior to screening, including fungal/bacterial/viral/parasitic infections, ocular herpes simplex, varicella, measles, etc.;
• Have had acute diseases within 2 weeks prior to screening until randomization (including acute appendicitis, acute gastroenteritis, acute cerebral infarction, cerebral hemorrhage, angina pectoris, upper gastrointestinal hemorrhage, etc.);
• Have used any drugs (including any prescription drugs, over-the-counter drugs, Chinese herbal preparations) or health supplements from 2 weeks prior to screening until randomization;
• Have undergone major surgery (excluding diagnostic surgery) from 6 months prior to screening until randomization, or have undergone surgery that, in the investigator's judgment, would affect the absorption, distribution, metabolism, or excretion of the drug, or are planning to undergo surgery during the study;
• Have an average weekly alcohol use of more than 14 units (1 unit = 360 mL of 5% alcohol beer or 45 mL of 40% alcohol spirits or 150 mL of 12% alcohol wine) from 3 months prior to screening until randomization, or are unable to abstain from alcohol during the study, or have an alcohol breath test result greater than 0.0 mg/100 mL;
• Have consumed foods or beverages that affect drug metabolism, such as chocolate, dragon fruit, mango, carambola, guava, pomelo, orange, grapefruit or grapefruit products, from 48 hours before dosing until randomization, or are unable to stop consuming them during the study;
• Have received any vaccine from 4 weeks prior to screening until randomization, or plan to receive any vaccine during the study (by inquiry);
• Have participated in any drug or device clinical study from 3 months prior to screening until randomization (participation is defined as receiving the investigational drug or device, and the end time is defined as the date of discharge from the last clinical study);
• Have a history of blood donation from 3 months prior to screening until randomization, or have a total blood loss of 400 mL or more from blood donation or other reasons within 6 months (excluding menstrual blood loss for females), or plan to donate blood within 6 months after the last blood collection;
• Have an average daily smoking of more than 5 cigarettes from 3 months prior to screening until randomization, or are unable to stop using any tobacco products during the study;
• Have a positive result for any item in the urine drug screen (including: morphine, methamphetamine (ice), ketamine (K powder), ecstasy (MDMA), marijuana (tetrahydrocannabinolic acid), etc.);
• Have used oral contraception from 30 days prior to screening until randomization;
• Have used long-acting estrogen or progesterone injections (including progesterone-releasing intrauterine devices) or implants from 6 months prior to screening until randomization;
• Have had unprotected sexual intercourse with a partner from 14 days prior to screening until randomization;

Other illness

• Allergic diathesis, a clinical history of allergies to food, drugs, etc., or a known history of allergy to budesonide, budesonide delayed release tablet, or excipients of budesonide delayed release capsules;
• Have a history of or currently have eye disorders (such as glaucoma, cataracts), or have a family history of glaucoma;
• Have a history of drug addiction or drug abuse (including non-medical use of various narcotic drugs and psychotropic drugs);
• Have difficulty with venipuncture or poor vascular conditions, or cannot tolerate venipuncture/indwelling needle, or have a history of fainting from needles or blood;
• Be unsuitable for enrollment or other situations where the participant is unable to participate for personal reasons as judged by the investigator.
  • Female participants who meet the following conditions, in addition to the above requirements, should also be excluded:

Lab values

• Have clinically significant abnormal results in vital signs, physical examination, clinical laboratory tests (hematology, urinalysis, clinical chemistry, 4-item coagulation test, 4-item infectious disease test) and ECG at screening, as judged by the investigator;

Other

• Have the following ECG findings at screening: prolonged QTcF interval (QTcF\>450 ms for males, \>470 ms for females);
• Have consumed tea, coffee, or beverages containing caffeine or alcohol from 48 hours before dosing until randomization, or are unable to stop consuming them during the study;
• Have lactose intolerance;
• Have special dietary requirements, or are unable to accept the standardized diet during the study;
• Have dysphagia;
• Have a positive pregnancy test;
• Are women who are pregnant or lactating.

• Fully understand the purpose, nature, procedures of the study and possible adverse reactions, voluntarily participate in the study, and sign the informed consent form (ICF) before any study procedures begin;
• Healthy male or female participants aged ≥18 years;
• Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index (BMI) in the range of 18.5 to 24.9 kg/m2 (inclusive);
• Voluntarily use effective contraception during the study and for 3 months after the last dose of the investigational product, and have no plans for childbirth, sperm donation, or egg donation;
• Able to communicate well with the investigator and understand and comply with all requirements of this study.