Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT06574204
Eligibility Criteria:
Inclusion Criteria:
* The age range of the subjects is from 18 to 65 years old, and there is no gender restriction for the subjects;
* Male subjects weigh more than 50kg (including 50kg) and female subjects weigh more than 45kg (including 45kg); Body mass index \[BMI= weight (kg)/ height (m) 2\] is in the range of 19-26 kg/m 2, including the critical value;
* The physical examination, laboratory examination, 12 lead electrocardiogram, chest X-ray (anterior lateral and lateral), and vital sign examination of the subjects are all within normal range or abnormal;
* The subjects' blood routine, blood biochemistry, and urine routine are within the normal range;
Exclusion Criteria:
* People have a clinical history of the following diseases (including but not limited to gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematological, psychiatric, renal, liver, bronchial, neurological, immune, lipid metabolism disorders, or known or suspected malignant tumors);
* Patients who experience abnormal bleeding within the first 6 months of screening do not meet the criteria;
* Pregnant and lactating women; Or female urine pregnancy test positive;
* Blood routine, blood biochemistry, and urine routine examination are significantly abnormal;
* Have a history of hospitalization or surgery within 6 months before screening;
* Participate in other drug clinical studies within 3 months before screening;
* Patients with a history of prescription drug abuse and illicit drug abuse or positive urine drug screening within 6 months before screening;
* A history of alcohol abuse in the 6 months before screening, that is, drinking more than 14 units of alcohol per week (1 single drink =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine);
* During the six months before screening, individuals who smoke more than 10 cigarettes per day or test positive for nicotine in their urine;
* Within the 3 months before screening, individuals consumed more than 1 liter of strong tea, coffee, and/or caffeinated beverages per day;
* Within 3 months before screening, the patient has a history of blood donation or acute blood loss (≥ 400mL)；
* Within 2 weeks before the screening, people use prescription drugs, over-the-counter drugs, traditional Chinese patent medicines, and simple preparations or Chinese herbal medicines;
* People have a history of allergy to any of the components of the test drug (erythromycin, azithromycin, other macrolides or ketolides);
* Any other factors deemed unsuitable for participation in this study by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06574204
Study Brief:
Protocol Section:
NCT06574204