bioequivalence in healthy volunteers
Conditions
Interventions
1:hydroxychloroquine sulfate tablet(Shanghai Zhongxi Pharmaceutical Co., Ltd.)
2:hydroxychloroquine sulfate tablet (Sanofi-Synthelabo Ltd.)
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
Male
Age
20 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1. voluntarily participate in clinical trials and provided informed consent; 2. healthy male volunteers aged 18-40 years, The age difference of the volunteers was not more than 10 years; 3. weight not less than 50Kg, and body mass index (BMI) within the range of 19-25 kg/m2, the weight deviation was not more than 10%; 4. No history of heart, liver, kidney, gastrointestinal tract, nervous system, mental disorders and metabolic disorders, no history of allergies, and no history of severe infections and serious injury; 5. Results or values of physical examinations, ECGs, an clinical laboratory tests are normal or within the acceptable range of sponsor/investigator; 6. Take reliable contraceptive measures during the study or 3 months post-dose; 7. No hobby of alcoho and smoking, prohibited from smoking, having food or beverages containing grapefruit juice, tobacco, alcohol, caffeine,and or xanthine 1 week before or during the study.
Exclusion criteria
Exclusion criteria: 1. Known severe allergies or allergic reactions to the test preparation, and/or any of its ingredients or the relative preparations; the absence of glucose-6-phosphate dehydrogenase; 2. History of diseases in central nervous system, cardiovascular, respiratory, digestive, genitourinary, endocrine and metabolic, hematopoietic system and spirit of the system; patients with psoriasis, porphyria patients and retinopathy; 3. History of disease that may affect the evaluation of preparations; History of surgery or medical conditions that may affect absorption, distribution, metabolism or excretion of preparations; 4. Posotive result of Hepatitis B surface antigen (HBsAg), HCV and HIV antibody; 5. Use of any prescriptions or Chinese herbal medicine 4 weeks before screening; Use of any non-prescription drugs and food supplements (vitamins, etc.) 2 weeks before screening; 6. Participated in any clinical trials 3 months before screening; 7. Blood donation or blood loss >=400mL 3 months before screening; 8. Has spontaneous abnormal eg, recurrent syncope, palpitations, etc., 1 year before screening and/or current; 9. History of alcohol abuse, more than a big bottle of beer everyday; 10. Do not follow the restrictions on alcohol and tobacco: smoking, drinking caffeinated beverages, or eat food or drink of any alcoholic or xanthine from 48 hours prior to drug administration till the end of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC; | — |
Countries
China
Contacts
Public ContactChen Yu
Shanghai Xuhui Central Hospital
Outcome results
None listed