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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT06438367
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult males
* Age between 18 and 45 years old (both limits included)
* Body weight index between 19.0 and 26.0 kg/m2 (both limits included), and body weight not less than 50.0kg
* Willing to consent
* Able to communicate with investigator and complete study according to study protocol
Exclusion Criteria:
* Clinically significant results from comprehensive physical and clinical examinations
* Positive results on hepatitis, HIV or syphilis
* Clinically significant results from eye examination
* Usage of inducer or inhibitor drugs to drug metabolism with 30 days prior to screening
* Usage of any prescription or non-prescription drug, Chinese herbal medicine or dietary supplements
* Presence of any significant medical history or clinical conditions that could affect study results per investigators' judgement
* Presence of any condition that could affect drug absorption
* Reception of major surgery within 6 months before screening, or surgical wounds not completely healed
* Presence of allergic reactions or may be allergic to ingredients in the investigational drug
* Presence of hemorrhoids, or having history of or is having conditions that cause bloody feces
* Habitual congestion or diarrhea
* Alcohol abuse or excessive alcohol consumption within 6 months before screening
* Excessive smoking within 3 months before screening
* Substance abuse or positive results on urine substance test
* Habits of grapefruit juice consumption or excessive caffeinated drinks consumption
* History of long-term exposure under radiation; or significant radiation exposure 1 year before this study; or participation in other radioactive drug studies
* Having difficulties to receive venous needle puncture, or cannot tolerate venous needle puncture, or history of hematophobia or needle sickness
* Participation in any other clinical studies within 3 months before screening
* Reception of vaccine within 1 months before screening, or planning to be vaccinated during the study
* Planning to have children or donate sperms during the study and within 1 year after the study, or Not agreeing to take contraceptive measures during and within 1 year after study completion
* Blood donation or blood loss of \> 400 ml within 3 months before screening; blood donation or blood loss of \> 200 ml within 1 month before screening; reception of blood transfusion within 1 months before screening, or planning to donate blood within 3 months after study completion
* Having special dietary requirements and unable to follow the uniform dietary plan in the study
* Any conditions that the investigator deemed unfit for the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06438367
Study Brief:
Protocol Section:
NCT06438367