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Genetic polymorphism affects the pharmacokinetic and pharmacodynamic of atorvastatin in healthy subjects

Genetic polymorphism affects the pharmacokinetic and pharmacodynamic of atorvastatin in healthy subjects

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-12002952
Enrollment
Unknown
Registered
2012-12-18
Start date
2012-10-24
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High cholesterol

Interventions

1:Amlodipine 5 mg, atorvastatin 10 mg

Sponsors

Institute of Clinical Pharmacology, Central South University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
19 Years to 29 Years

Inclusion criteria

Inclusion criteria: 1. healthy male volunteers, aged 18 to 40 years, including the boundary values; same batch age difference is not more than 10 years old; 2. weighing more than 50 kg, subjects body mass index (BMI) between 19 ~ 24 kg/m2, including the boundary values, the same batch of the weight difference should not be disparity; 3. physical examination no abnormal findings; d) no history of drug allergy; 4. Non-smoking, wine hobby; 5. subjects voluntarily participate in the trial and willing to be tested in accordance with the test procedures prescribed; 6. signed informed consent.

Exclusion criteria

Exclusion criteria: 1. four weeks before the test suffered from clinically significant disease or accepted surgery; 2. the results of any laboratory tests the presence of clinically significant abnormal situation; 3. Routine blood tests, white blood cells is greater than or equal to 10x10^9/L; 4. have a history of any clinical history of serious illness or cardiovascular system, endocrine system, nervous system disease or lung, hematology, immunology, psychiatry diseases and metabolic abnormalities; 5. HIV test positive; 6. hepatitis B surface antigen positive or hepatitis C testing positive; 7. ongoing concomitant treatment has any medical significance; 8. skin acne, redness; 9. to participate in the trial within 14 days of concomitant medication; 10. to participate in the test 14 days before the use of vitamins or other health care products; 11. drug abuse history; 12. 3 month trial period before the test taking soft drugs (such as the year before and during the trial: marijuana) or test taking hard drugs (such as: cocaine, benzene ring has piperidine, etc.) who; 13. within three months to participate in other drug trials; 14. within 3 months before the test in blood donors; 15. suffering from coagulation disorders or thromboembolic disease.

Design outcomes

Primary

MeasureTime frame
Pharmacokinetics and pharmacodynamics indexe;

Countries

China

Contacts

Public ContactOUYANG Deng-sheng
ouyangyj@163.com+86 13307313736

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026