Iron Deficiency Anemia
Conditions
Interventions
2:group1: 200-mg test (ferrous succinate, 100 mg*2, Hunan Huana Pharmaceutical Co., Ltd., China), group 2: 200-mg reference (Sulifei 100 mg*2, Nanjing Jinling Pharmaceutical Co. Ltd., Nanjing, China)
Sponsors
Beijing Hospital Clinical Trial Center
Eligibility
Sex/Gender
Male
Age
21 Years to 39 Years
Inclusion criteria
Inclusion criteria: 1. Healthy Chinese male subjects, 18 to 40 years of age, Body weight >50Kg, BMI19 to 25 kg/m2; 2. body temperature 35.0-37.0 degree C; systolic blood pressure 90-140 mmHg, diastolic blood pressure60-90 mmHg, pulse rate 50 - 90 bpm.
Exclusion criteria
Exclusion criteria: 1. Heavy smoker (>5 cigarette per day); 2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric diseases; 3. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases; 4. A past medical history of clinically significant ECG abnormalities or a family history of a long QT-interval syndrome; 5. History of multiple and recurring allergies or allergy to the investigational compounds /compound classes being used in this study; 6. Participation in any clinical investigation within 30 days prior to initial dosing; 7. Donation or loss of 400 ml or more of blood within 8 weeks prior to first dosing, or longer if required by local regulation; 8. Use of any medication, including over-the-counter and herbal products, or dietary supplements (vitamins included and calcium formulations) within 7 days of the first drug administration in this study; 9. Use of iron supplements with 3 months of the first drug administration; 10. Serum iron values less than 1000ug/L or Hb less than 12 mg/dL; 11. History of gastric acid or Vitamin B12 deficiency; 12. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study. The investigator should be guided by evidence of any of the following: (1) history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding; (2) history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; (3) history or clinical evidence of pancreatic injury or pancreatitis; (4) clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as SGOT (AST), SGPT (ALT), garma-GGT, alkaline phosphatase, or serum bilirubin; (5) SGPT (AST) will have to be strictly within the normal range before inclusion, garma-GGT and alkaline phosphatase must not exceed twice the upper limit of the normal range, serum bilirubin should not exceed the value of 27umol/L (1.6 mg/dl); (6) history or presence of impaired renal function as indicated by clinically significantly abnormal creatinine or BUN and urea values, or abnormal urinary constituents (e.g., albuminuria); (7) evidence of urinary obstruction or difficulty in voiding at screening; 13. Total WBC count which falls outside the range of 4000–10,000/ul, or platelets <100,000/ul at screening; 14. History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Iron Concentration; | — |
Countries
China
Contacts
Public ContactCao Guo Ying
Beijing Hospital
Outcome results
None listed