Hyperlipidemia
Conditions
Interventions
T:pitavastatin calcium tablet (test product)
R1:pitavastatin calcium tablet (reference product)
R2:pitavastatin calcium tablet (reference product)
Sponsors
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Gender: healthy male; 2. Aged 18-45 years old, the age difference within the same batch of subjects no more than 10 years old; 3. Weight:the weight of all subjects must be greater than 50 kg with BMI between 19 and 24 kg/m2(BMI = weight (kg)/height (m2))including the boundary values; 4. Physical and laboratory examination showed normality of various systems and vital signs; 5. According to GCP regulations,subgects obtain informed consent and are voluntarily subjected.
Exclusion criteria
Exclusion criteria: 1. People who had disease of clinical significance or underwent surgery 4 weeks before the experiment; 2. People who are explicitly allergic to the product or its formulation ingredients; 3. People with primary disease of the heart, liver, kidney and other vital organs, history of gastrointestinal disease, history of metabolic disease, neurological diseases, endocrine system diseases or history of lung disease, hematological diseases, immunological diseases, psychiatry disease; 4. People with history of severe migraine or headache, gallbladder disease of clinical significance, malignancy, with coagulation disorders or thromboembolic disease; 5. People whose physical and chemical examination (blood routine, urine routine, blood biochemistry, ultrasound, chest fluoroscopy, ECG) results revealed abnormality of clinically diagnostic significance within 1 week before the test; 6. Peole with abnormal vital signs (Systolic blood pressure90 mmHg; heart rate100 bpm); 7. People with history of drug dependence, drug abuse or alcoholism; 8. People who were regular drinkers within 6months before the test, drinking more than 14 units alcohol per week (1 unit = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine); people who sucked more than 1 cigarette per day within 3 months before the test; 9. People who took soft drugs such as marijuana within 3 months before the test or hard drugs such as cocaine, phencyclidine and so on within 1 year before the test; 10. People who took drugs that inhibit or induct drug metabolism by liver, such as inducers-barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; inhibitors-SSRI antidepressants, cimetidine, diltiazem macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines; 11. People who have excessive daily consumption of tea, coffee and / or caffeinated beverages (more than 8 cups); 12. People who had any drugs within 14 days before the test; 13. People who participated in any drug clinical trial within 3 months before the test; 14. People who donated blood within 3 months before the test; 15. People who are unsuitable for the test such as infirmity according to the judgment of researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration pitavastatin calcium in plasma; | — |
Countries
China
Contacts
Public ContactYuhong Huang
Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed