Bioequivalence Study of ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions

Korábbi kezelés

• Subjects with a history of allergy (allergic to two or more drugs or foods), or known allergy to the investigational product or its excipients.
• Subjects who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the trial, and those who have undergone any surgery that could affect the absorption, distribution, metabolism, or excretion of the drug.
• Subjects who have taken any other investigational drug or participated in any other medical or drug clinical trial within 3 months prior to screening.
• Subjects who have received any vaccination within 1 month prior to screening.
• Subjects who have donated more than 400 mL of blood or experienced significant blood loss (>400 mL) within 3 months prior to screening, or who plan to donate blood during the trial or within one month after the end of the trial.
• Subjects who have a smoking habit (average of ≥5 cigarettes per day) within 3 months prior to screening, or who are unable to abstain from using any tobacco products during the trial.
• Subjects who have consumed more than 14 units of alcohol per week within 6 months prior to screening (1 unit of alcohol = 360 mL of beer, or 45 mL of spirits with 40% alcohol, or 150 mL of wine), or who are unable to abstain from alcohol during the trial, or who have a positive alcohol screening test.
• Subjects with a positive drug abuse screening test, or a history of drug abuse, or who have used illicit drugs within 3 months prior to screening.
• Subjects who have taken any prescription drugs, over-the-counter medications, health supplements, or herbal medicines within 14 days prior to screening.

Más betegség

• Subjects with any history of clinically significant disease, or history of cardiovascular, endocrine, neurological, digestive system diseases, or pulmonary, hematological, immunological, psychiatric diseases, and metabolic abnormalities.
• Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis screening.
• Subjects who develop any new illness or use any new medication (including prescription drugs, over-the-counter medications, health supplements, or herbal medicines) during the period from screening to admission on Day -1.
• Subjects with difficulty in blood collection or a history of needle phobia or vasovagal syncope associated with blood draws.

Laborértékek

• Subjects with abnormalities in physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory tests that are deemed clinically significant by the investigator.

Egyéb

• Female participants who are lactating or have a positive pregnancy test during the screening period or during the trial.
• Subjects with special dietary requirements who are unable to comply with the standardized diet.
• Subjects who are unable to complete the trial due to other reasons, or who are deemed unsuitable for enrollment by the investigator.

• Healthy adult males and non-pregnant, non-lactating healthy adult females, aged 18 to 55 years (inclusive) at the time of signing the informed consent form. Subjects who exceed 55 years of age during the trial will not be excluded.
• Weight: males ≥ 50.0 kg, females ≥ 45.0 kg; body mass index (BMI) [BMI = weight (kg)/height² (m²)] between 19.0 and 26.0 kg/m² (inclusive).
• Participants (including their partners) are willing to have no pregnancy plan from the screening period until 6 months after the end of the trial, voluntarily use effective contraceptive measures, and have no plans for childbearing or sperm/egg donation.
• Fully understand the content of the informed consent form, voluntarily sign it, and voluntarily participate in the trial.
• Able to complete the study according to the requirements of the trial protocol.