Gastrointestinal Stromal Tumors?renal cell carcinoma
Conditions
Interventions
Group 1:Sunitinib Malate Capsules produced by CSPC Ouyi Pharmaceutical Co., Ltd
Group 2:Sunitinib Malate Capsules produced by Pfizer Italia S.r.l.
Sponsors
The first hospital of Jilin university
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) To be able to understand and provide written informed consent and voluntary consent to participate in the study; 2) To be able to complete the study in compliance with the protocol; 3) No birth plan during the study and within 6 months after the study; 4) Healthy male Chinese volunteers aged from 18 to 65 (including 18 and 65); 5) BW more than 50 kg, BMI between 18 to 28 (including the criticals); 6) Healthy status: no heart, liver, kidney, digestive system, nervous system, mental disorders and metabolic disorders and other medical history; 7) Physical examination is normal or determined by no clinically significant.
Exclusion criteria
Exclusion criteria: 1) Consume more than 5 cigarettes per day or the equivalent within three months before the test; 2) Have known allergies to compounds related to gefitinib; 3) The subjects have a history of drug and /or alcohol abbuse (alcohol in take 14 units weekly:1 unit=285ml beer,or 25ml liquor,or 1 cup of wine); 4) Have a blood donation or blood loss (450 ml)within three months before taking research drugs; 5) if the subjects taking any drugs of changing the liver enzyme activity or not within 28 days before taking medicine; 6) have taken any prescription,non-prescriiption drugs ,any vitamin products or herbs within 14 days prior to the study; 7) take over special diet (including pitava,mango,pomelo,and/or xanthine diet)or taking strenous exercise, or the other factors that affect drug absorption,distribution, metabolism and excretion within 2 weeks before the test; 8) Use any inhibitors or inducers associated with CYP3A4 Bcrp or P-gp, such as itraconazoleketoconazole, or dornedarone, ect.; 9) If there were any major changes or not on a diet or exercise habits recently; 10) Whether to take study drug or participated in drug clinical trials within three months before the study; 11) Have a history of gastrointestinal diseases about difficulty swallowing or any effects of drug absorption; 12) Suffering from any increased bleeding risk of diseasas such as hemorrhoids,acute gastritis or gastric and duodenal ulcers ect; 13) Abnormal ECG have clinical significance; 14) Clinical laboratory examination were abnormal clinical significancce or other clinical findings show that there are cllinical significance of the following diseases (including but nnot limited to the gastrointestinal tractkidney liver neural blood endocrine tumor lung immune mental or cardiovascular disease; 15) Have hepatitis (including hepatitis B and C) and tested positive for HIV/AIDS screening; 16) Acute illness happened before the screening stage prior to the study or before taking study drugs; 17) The subjects intake of chocolate,any caffeinated,or xanthine-containing food or drinks within 48 hours before taking study drugs; 18) Use any alcoholic products within 24 hours before taking study medication; 19) The subjects Screened positive for drug and alcohol or had has a history of substance abuse in the past five years or used drugs 3 months before the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety indicators; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed