Investigations on relations between SNPs in statin-related transporters and metabolizing enzymes and pharmacokinetics of fluvastatin, simvastatin, rosuvastatin and pitavastatin

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TTRCC-12002290

Enrollment

Unknown

Registered

2012-06-23

Start date

2006-08-24

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

not disease-related

Interventions

fluvastatin:Retrospective analysis of pharmacokinetics data and collect 5ml blood for genotying

simvastatin:Retrospective analysis of pharmacokinetics data and collect 5ml blood for genotying

rosuvastatin calcium:Retrospective analysis of pharmacokinetics data and collect 5ml blood for genotying

pitavastatin calcium:Retrospective analysis of pharmacokinetics data and collect 5ml blood for genotying

Eligibility

Sex/Gender

All

Age

20 Years to 25 Years

Inclusion criteria

Inclusion criteria: fluvastatin, simvastatin 1. male healthy subjects; 2. aged 18-40years; 3. Body weight (more than 50kg), BMI(19-25kg/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.Rosuvastatin, pitavastatin: (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. Investigator thinks that the subjects are not suitable for participating the clinical trial.

Design outcomes

Primary

Measure	Time frame
SNP;	—

Countries

China

Contacts

Public ContactQuan Zhou

zhouquan142602@zju.edu.cn+86 13588758501

Outcome results

None listed

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