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Bioequivalence study of simvastatin tablets in human

Bioequivalence study of simvastatin tablets in human

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-12002292
Enrollment
Unknown
Registered
2012-06-22
Start date
2005-09-14
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

Experimental:oral ingestion of a single dose of simvastatin tablets
Reference:oral ingestion of a single dose of simvastatin tablets

Sponsors

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

Eligibility

Sex/Gender
Male
Age
22 Years to 25 Years

Inclusion criteria

Inclusion criteria: 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.

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)Invesigator thinks that the subjects are not suitable for participating the clinical trial.

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of simvastatin;

Countries

China

Contacts

Public ContactZou-rong Ruan

The Second Affiliated Hospital, School of Medicine, Zhejiang University

ruanzr@126.com+86 0571-87783891

Outcome results

None listed

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