Chinese adult healthy volunteers
Conditions
Interventions
[14C]Icaritin:Take 4 capsules orally contain 600 mg Icaritin (containing radioactive is about 7.4 MBq, 200 Ci)
Sponsors
The First Hospital Affiliated of Soochow University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Those who meet all the following conditions are eligible for the study: 1) healthy adult males; 2) aged 18~45 years of age (including boundary value); 3) body weight: body mass index (BMI) between 19~26 kg/m2 (including boundary values); 4) voluntary signing of informed consent; 5) volunteers can communicate well with investigators and be able to perform tests in accordance with the requirements of the program.
Exclusion criteria
Exclusion criteria: Laboratory examination: 1) the investigators estimate the the abnormality of laboratory tests (blood routine, urine routine, stool routine + occult blood, blood biochemistry, blood routine, chromosome aberration, micronucleus rate)is of clinical significance; 2) The abnormalities of The ECG in the screening period is clinical significance; 3) abnormal of life signs (systolic pressure 140 mmHg, diastolic pressure 90 mmHg; heart rate 100 BPM); 4) positive hepatitis B surface antigen test or HCV antibody positive test; 5) positive for HIV antibody test; 6) positive for syphilis detection. Medication history: 7) take any drugs that inhibits or induces the metabolism of drugs in the liver within 30 days before the screening period (such as inducer - barbiturates, phenytoin,carbamazepine, glucocorticoid, Omeprazole; inhibitor SSRI antidepressants, cimetidine, Diltiazem macrolide, nitromidazoles, sedatives, Vera Pammy fluoroquinolones, antihistamines); 8) take any medication within 14 days before the screening period; 9) take any clinical trial drug, or take part in any clinical trial within three months before the screening period, or prepare for other clinical trials within 1 months after the end of the trial; History of disease and surgical history: 10) who suffered from organic heart disease, heart failure, myocardial infarction, angina pectoris, arrhythmia, can not explain the history of torsades de pointes ventricular tachycardia history, long QT syndrome or long QT syndrome symptoms or have family historyof heart disease (Genetic proof or Close relatives show sudden death due to cardiac causes at a young age); 11) the patients who had undergone major surgery within 6 months before the screening period; 12) there is a history of any serious disease that includes, but not limited to, circulatory, endocrine, nervous, digestive, urinary, or blood, immune, psychiatric, and metabolic diseases; 13) allergic persons, including clear flavonoids or any excipients allergy, any food ingredients allergies or special requirements on the diet, can not comply with a unified diet; 14) suffering from blood coagulation disorders and other blood system diseases; 15) those with a history of cancer; Lifestyle: 16) habitual constipation; 17) drinking regularly during the first 6 months of alcoholism or screening, i.e., drinking more than 14 units of alcohol per week (1 units =360 ml beer or 45 ml alcohol, 40% spirits or 150 ml wines); 18) smoking or more than 1 cigarettes per day for 3 months before or during the screening period, and can not be abstinent during the test period; 19) drug abuse or take soft drugs (e.g. cannabis) within 3 months before screening period, or take hard drugs (such as cocaine, amphetamines, piperidine, etc.) within 1 years before the screening period; 20) habitual consumption of grapefruit juice or excessive tea, coffee, and / or caffeinated beverages and can not abstinent during the test period; Other: 21) engage in workers who are exposed to radiation for a long time, or more than 5 X ray examinations were performed or participated in the radiopharmaceutical labeling test within 1 years prior to the trial; 22) during the period of the trial and after the completion of the trial, there were fertility planners within 2 years, or did not agree that the volunteers and their spouses should adopt strict contraceptive measures within 2 years after the trial and after the co
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radioactivity;Blood concentration; | — |
Countries
China
Contacts
Public ContactLiyan Miao
The First Hospital Affiliated of Soochow University
Outcome results
None listed