About this trial
Last updated a year ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 8 months ago
What is this trial about?
What are the participation requirements?
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