Pharmacokinetics and Bioequivalence Study in human
Conditions
Interventions
1:Phase I: Europharm Lab. Co. Ltd. produced Atorvastatin, 40 mg/tablet
Phase II: Pfizer Manufacturing Deutschland GmbH produced Lipitor Tab
2:Phase I: Pfizer Manufacturing Deutschland GmbH produced Lipitor Tab
Phase II: Europharm Lab. Co. Ltd. produced Atorvastatin, 40 mg/tablet
Sponsors
Xiangya Boai Rehabilitation Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Age ranging 18~55 years old, both males and females with suitable ratio in the study; 2. Body weight of male >=50 kg, body weight of female >=45 kg, and Body Mass Index (BMI) ranged within 19 ~26 kg/m2 including boundary values; 3. All subjects signed the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any clinically serious disease that has been or is currently suffering from circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities; (screening period); 2. Those who have a history of allergies to drugs (atorvastatin or statins), food or other substances; (screening period); 3. Surgery within 4 weeks before the trial, or scheduled for surgery during the study; (screening period); 4. Anyone who has used any drug within 14 days before the test (including Chinese herbal medicines and health care products); (screening period, check-in period); 5. Any drug that inhibits or induces liver metabolism of the drug within 30 days prior to the test (eg, inducer - barbiturate, carbamazepine, phenytoin, glucocorticoid, omeprazole; inhibitor - SSRI resistance) Depressive drugs, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines; (screening period); 6. Any other clinical trial drugs or clinical trials of any other drug used within 3 months prior to the trial; (screening period, check-in period); 7. Those who have donated blood or accidentally lost more than 200 mL within 3 months before the test; (screening period, check-in period); 8. Unprotected sexual behavior occurs during pregnancy and lactation, or during the test period and within 3 months after the test, and one or more contraceptive measures cannot be taken; (screening period, check-in period); 9. Those who have special requirements for diet and cannot follow the unified diet; (screening period); 10. Drink excessive tea, coffee and beverages rich in caffeine or jaundice (8 cups or more, 1 cup = 250 mL) per day; (screening period, check-in period); 11. Have eaten grapefruit juice, grape juice, cabbage vegetables, dragon fruit, mango, orange or food or drink prepared from it within 2 days before the test; (screening period, check-in period); 12. smokers or more than 5 cigarettes per day for the first 3 months of the trial; (screening period, check-in period); 13. Alcoholics or those who regularly drink alcohol within 6 months before the test, that is, drinking more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine); check-in period) 14. Drug abusers or soft drugs (such as marijuana) used within 3 months before the test or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year before the test (screening period); 15. Abnormal vital signs (systolic blood pressure 140 mmHg, diastolic blood pressure 90 mmHg; pulse 100 bpm) are clinically significant (subject to the judgment of the research physician); Period, check-in period); 16. If the physical examination, electrocardiogram, or laboratory examination is clinically significant (subject to the judgment of the research physician); (screening period); 17. vasovagal syncope, poor vascular conditions or difficulty in puncture; (screening period); 18. Patients with abnormal clinical significance of blood pregnancy (ß-HCG) examination (only for female subjects); (screening period, check-in period); 19. Subjects are poorly compliant, unable to complete the study for other reasons or those the investigator believes should not be included; (screening period, check-in period); 20. Alcohol breath test results greater than 0.0 mg / 100 mL; (stay period); 21. urine drug screening (m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atorvastatin; | — |
Countries
China
Contacts
Public ContactZhang Bikui
Xiangya Boai Rehabilitation Hospital
Outcome results
None listed