A randomized, open-label trial for bioequivalence of Atorvastatin Calcium Tablets (specification 20mg) in Chinese healthy volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800018284

Enrollment

Unknown

Registered

2018-09-09

Start date

2018-09-20

Completion date

Unknown

Last updated

2018-09-10

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

Conditions

Pharmacokinetics and bioequivalence

Interventions

1:Group 1: atorvastatin calcium tablets produced by Hunan Tianji Cao Tang Pharmaceutical Co.,LTD

Group 2: atorvastatin calcium tablets produced by Pfizer Pharmaceuticals LLC

Group 2:Group 2 giving atorvastatin calcium tablets produced by Hunan Tianji Cao Tang Pharmaceutical Co.,LTD

Group 1: atorvastatin calcium tablets produced by Pfizer Pharmaceuticals LLC

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~45 years; 2. BMI 19~26; 3. All subjects are voluntary to take part in the trial and signed the informed consent form; 4. Subjects can communicate well and complete the study.

Exclusion criteria

Exclusion criteria: 1. serious disease or receive major surgery 4-week within study; 2. allergy to the study drug; 3. Diseases of the cardiovascular system patients (hypertension, hyperlipidemia,arrhythmia, cardiac insufficiency, and et al.); 4. history of severe disease or endocrine system, nervous system disease, lung, blood, immunology, psychiatric disease and metabolic disorder; 5. history of some diseases that can influence drug absorption and metabolic; 6. laboratory tests (blood routine, urine routine, liver and kidney function, blood glucose, blood lipid, abnormal ion) has a clincal significance; 7. electrocardiogram and physical examination have a clinical significance; 8. HIV and RPR test were positive; 9. hepatitis B surface antigen and hepatitis C antibody were positive; 10. alcoholics 3 months before study; 11. soft drug users (ecstasy, KEN, Magu, et al) within 3 months or hard drugs users (cocaine, diamorphine, et al) within 1 year; 12. use of drug-metabolizing- enzyme-modifying drugs within 30 days of admission; 13. any drug users 14 day before study; 14. Blood donator 3 months before study; 15. Daily smoking more than 5 minths before study; 16. have special requirements on food; 17. tea or coffee abusers; 18. other reasons.

Design outcomes

Primary

Measure	Time frame
plasma concentration of atorvastatin;	—

Countries

China

Contacts

Public ContactXu Pingsheng

Xiangya Hospital, Central South University

xups2004@126.com+86 0731-84327458

Outcome results

None listed

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