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Pharmacokinetics study of rosuvastatin calcium tablets

Pharmacokinetics study of rosuvastatin calcium tablets

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-12002289
Enrollment
Unknown
Registered
2012-06-23
Start date
2005-07-01
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

Hypercholesterolemia (phase II)

Interventions

5mg:oral ingestion of a single dose of rosuvastatin tablets (5mg)
10mg:oral ingestion of a single dose of rosuvastatin tablets (10mg)
20mg:oral ingestion of a single dose of rosuvastatin tablets (20mg)
10 mg multiple dose:oral ingestion of a single dose of rosuvastatin tablets (10mg)

Sponsors

The Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 25 Years

Inclusion criteria

Inclusion criteria: 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 months; 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 abnormal; 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. Invesigator thinks that the subjects are not suitable for participating the clinical trial.

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of rosuvastation;

Countries

China

Contacts

Public ContactJiang Shan
ruanzr@126.com+86 0571-87783891

Outcome results

None listed

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