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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT06775834
Eligibility Criteria:
Inclusion Criteria:
1. Sign the informed consent before the trial, and fully understand the content, process and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 65 (including 18 and 65);
3. Body mass index (BMI) ranges from 19 kg/m2 to 28 kg/m2 (including 18 and 28);
4. The glomerular filtration rate should meet the following criteria (GFR, mL/min): Subjects with mild renal impairment: 60-89 mL/min; Subjects with moderate renal impairment: 30-59 mL/min.
Exclusion Criteria:
1. Suspected allergy to the study drug or any component of the study drug;
2. Patients with cardiogenic shock, severe conduction block, sick sinus syndrome, heart failure, sustained tachyarrhythmia, torsades de pointes (Tdp) or ventricular tachycardia, history of clinically significant T wave changes, myocardial infarction, angina pectoris;
3. People with conditions associated with reduced neuromuscular transmission (myasthenia gravis, Lambert-Eaton syndrome, Duchenne muscular dystrophy);
4. Patients with a history of gastric or intestinal surgery that may affect drug absorption;
5. Participants with renal insufficiency who were judged by the investigator to be ineligible for the study;
6. Patients with large fluctuations or rapid deterioration of renal function within 2 weeks before administration, as judged by the investigator;
7. Subjects receiving renal replacement therapy within 3 months of the screening period or during the expected trial period;
8. Within 3 months before screening, patients with underlying diseases that induced chronic kidney disease and were poorly controlled according to the investigator's evaluation.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06775834
Study Brief:
Protocol Section:
NCT06775834