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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT05976503
Eligibility Criteria:
Inclusion Criteria:
1. Participants who can understand and are willing to strictly follow the clinical trial protocol to complete the trial and sign the informed consent;
2. Male participants aged 18\~45 years (including the cut-off value);
3. Weight≥50.0kg; Body mass index (BMI) in the range of 19.0\~26.0kg/m\^2 (including the critical value);
4. Good health, no history of respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, mental system and other serious diseases or chronic diseases;
5. Do not plan to have children during the trial, and agree to use reliable contraception during the trial and for 3 months after the last study drug administration, and do not plan to donate sperm.
Exclusion Criteria:
1. Allergic: allergic to drugs, food, pollen, alcohol, etc., known to be allergic to experimental drugs or other PDE5 inhibitors and excipients;
2. Patients with difficulty swallowing tablets/capsules; Or according to 0.5g/kg body weight intake of alcohol (that is, 70kg body weight participants drink 35g pure alcohol, equivalent to 50 degrees of liquor about 70g) may be intoxicated; Or have special dietary requirements and cannot accept the standard diet provided by the research center;
3. Patients who have a history of needle fainting and blood fainting, can not tolerate venous puncture blood collection and/or have difficulty in blood collection;
4. Patients with abnormal color vision judged by researchers to have clinical significance; Or have known to have retinitis pigmentosa, macular degeneration, nonarteriotic anterior ischemic optic neuropathy (NAION) eye disease; Or have known fundus medical history that other investigators have deemed unsuitable for inclusion;
5. People who have experienced sudden hearing loss or hearing loss in the past;
6. Past or existing postural hypotension/syncope;
7. Clinically significant vital signs (reference value range: 90 mmHg≤systolic blood pressure (sitting) \<140 mmHg, 60 mmHg≤diastolic blood pressure (sitting)\<90 mmHg, 55 times/min≤pulse rate (resting)≤100 times/min, 35.5℃≤body temperature (axillary temperature)≤37.2℃; Participant to the judgment of the study physician); Or physical examination, 12-lead electrocardiogram, laboratory test results, the investigator judged that the abnormality is clinically significant;
8. Hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum specific antibody, human immunodeficiency virus antibody any abnormal clinical significance;
9. Those who have used soft drugs (such as cannabis) within 3 months before screening or hard drugs (such as cocaine, amphetamines, Phencyclidine, etc.) within 1 year before screening; Or have a history of drug abuse; Or positive urine drug screening before randomization;
10. Positive breath test for alcohol;
11. Smokers who have smoked more than 5 cigarettes per day in the 3 months before screening or could not stop using any tobacco products during the test;
12. Participants in any clinical trial within 3 months prior to screening;
13. Those who have participated in blood donation and total blood donation or total blood loss≥400mL within 3 months before screening, or participated in blood donation and total blood donation≥200mL or total blood loss≥200mL within 1 month; Or receiving blood transfusion; Or plan to donate blood within 1 month after the end of this trial;
14. Those who have undergone surgery within 30 days prior to screening, or plan to undergo surgery during the trial;
15. Those who have received vaccination within 30 days prior to screening, or who plan to receive vaccination during the trial;
16. Use of any CYP3A4/5 inhibitors or inducers (e.g., inhibitors-itraconazole, fluconazole, clarithromycin, ritonavir, cimetidine, diltiazem, etc.) within 28 days prior to randomization; Inducers-rifampicin, phenobarbital, carbamazepine);
17. Those who have taken any prescription drugs, non-prescription drugs, health products, vitamins, or Chinese herbs within 14 days before randomization;
18. Those who have eaten grapefruit, pomelo, dragon fruit, mango and other fruits or related products that affect metabolic enzymes within 7 days before randomization;
19. People who ingested beverages or foods rich in caffeine or xanthine (such as coffee, strong tea, chocolate, cola, etc.) within 48 hours before randomization;
20. Patients who developed acute disease from the screening stage to before randomization;
21. Participants judged by the investigator to be unsuitable for this clinical trial.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05976503
Study Brief:
Protocol Section:
NCT05976503