capillary diseases
Conditions
Interventions
Fasting group:Reference preparation or test preparation was administered under fasting state in two periods
Fed group:Reference preparation or test preparation was administered after high fat diet in two periods
Sponsors
Phase I Clinical Research Centre , Shanghai Xuihui Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 40, male or female; 2) Weight: male =50 kg, female =45 kg; Body mass index (BMI) in the range of 19-26 kg/m2 (including the critical value); 3) No history of diseases such as artless, liver, kidney, digestive tract, nervous system, mental and metabolic abnormalities, and no history of serious infection or serious injury; 4) The important indicators of physical examination, vital signs examination, electrocardiogram examination and laboratory examination are normal or within the acceptable range considered by the investigator; 5) During the trial period and within 3 months after the last medication, no child care plan and reliable contraceptive measures can be taken; 6) Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent, and be able to complete the whole trial process according to the requirements of the trial.
Exclusion criteria
Exclusion criteria: 1) known allergic history, allergic disease or allergic constitution to test preparations and any of their components or related preparations; 2) Have a history of any diseases that may affect the safety of participating in the study or the in-vivo process of the tested drug, including the history of diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immunology, psychiatry and metabolic abnormalities; 3) Blood donation or blood loss =400 mL within 3 months before inclusion; 4) Those who have taken any drugs within 2 weeks prior to screening; 5) Participants in clinical trials of other drugs within 3 months prior to inclusion; 6) Current or former drug user, or previous alcoholic (i.e., more than 28 standard units per week for men and 21 standard units per week for women. 1 Standard units containing 14 g alcohol, such as 360 mL beer or 45 mL 40% alcohol spirits or 150 mL wine), or drinking regularly (more than 14 standard units per week) within 3 months prior to the trial; 7) Smokers who smoke more than 10 cigarettes a day; 8) Hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody, HIV antibody positive; 9) Positive pregnancy test (for women); 10) Positive breath tests for substance abuse (morphine, THC, methylamphetamine, dimethylene dioxy-amphetamine, ketamine and cocaine) or alcohol; 11) Abnormal and clinically significant chest X-ray examination results (anteroposterior); 12) Other factors that the investigator considers inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of calcium dobesilate;The max Concentration;The Area Under Concentration; | — |
Countries
China
Contacts
Public ContactYanmei Liu
Outcome results
None listed