not disease-related
Conditions
Interventions
1mg:oral ingestion of a single dose of pitavastatin dispersible tablet (1mg)
2mg:oral ingestion of a single dose of pitavastatin dispersible tablet (2mg)
4mg:oral ingestion of a single dose of pitavastatin dispersible tablet (4mg)
2mg:oral ingestion of multiple doses of pitavastatin dispersible tablet (2mg)
Sponsors
The 2nd Affiliated Hospital, School of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
20 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1. healthy subjects(male:female=1:1); 2. aged 20-30years; 3. Body weight (more than 45kg), BMI (19-24kg/m2); 4. without significant medical history and history of drug allergy; 5. non-drug abuser; 6. non-smokers and alcohol abuse; 7. All volunteers were not allowed to take any medications 2 wk before the study period; 8. volunteers can communicate well with investigator and obey the rules of the study; 9. All volunteers gave their written informed consent.
Exclusion criteria
Exclusion criteria: 1. subjects who paticipated in other clinical trials within the past 2 mo; 2. subjects who donated blood within the past 1 mo or will donate blood during or after the study; 3. subjects who do not pass the general physical examinations and BP, HR or breath status are not well; 4. subjects who have significant clinical symptoms by physical examination; 5. subjects who have some health problems by electrocardiogram and laboratory tests (including complete blood count, blood biochemistry testing and urinalysis) before starting this study; 6. Invesigator thinks that the subjects are not suitable for participating the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentrations of pitavastatin acid and pitavastatin lactone; | — |
Countries
China
Contacts
Public ContactJiang Shan
The Second Affiliated Hospital, School of Medicine, Zhejiang University
Outcome results
None listed