healthy volunteer
Conditions
Interventions
1:Sulfadoxine/Pyrimethamine FDC tablet (Guilin Pharmaceutical Co., Ltd)
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
Male
Age
19 Years to 28 Years
Inclusion criteria
Inclusion criteria: 1. healthy male volunteers aged 18-45 years, the age difference of the volunteers was not more than 10 years; 2. Past medical history, physical examination, vital signs and laboratory tests showed no abnormality value or no abnormal clinical significance; 3. Body weight within the range for standard weight, and body mass index(BMI)within the range of 20-24kg/m2; 4. voluntarily participate in clinical trials and provided informed consent; 5. Subjects who are willing and able to comply with scheduled visits, treatment plan, blood sample collection and other study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects are Known to be allergic to the study medications or any other medications in the same class; 2. Evidence or history of clinically significant cardiovascular, endocrine, gastrointestinal tract, hematological, hepatic, pulmonary, renal, neurological, and psychiatric diseases; 3. Any clinial laboratory tests results outside the normalrange and considered clinically significant by the PI; 4. use of prescription or non-prescription drugs including Chinese Traditional Medicines within 14 days prior to the first dose of study medication; 5. use of an investigational drug or participation in an investigational trials within 30 days prior to dosing; 6. history of drug dependency or drug abuse; 7. history of alcohol abuse (more than 14 drinks per week, 1 drink = 360ml of beer, or 150mL of white wine or 45mL of hard liquor) who; 8. daily smokers of 10 or more; 9. blood collection was difficult; 10. Blood donation 3 months before dosing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cma; | — |
Countries
China
Contacts
Public ContactYan-Mei Liu
Shanghai Xuhui Central Hospital
Outcome results
None listed