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Bioequivalence Study of Sirolimus Tablet

The study of pharmacogenetics and clinical safety profiles of sirolimus

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TTRCC-12002118
Enrollment
Unknown
Registered
2012-03-19
Start date
2010-01-07
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

immunosuppression

Interventions

J:Oral 6mg the reference tablets
y:Oral 2mg the test tablets

Sponsors

First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 27 Years

Inclusion criteria

Inclusion criteria: 1. Male, Aged from 18 to 40 years old, no more than 10 years in age difference of thee subjects in the same group; 2. BMI ranged from 19 to 25 kg/m2; 3. No history of organic disease and drugallergy; 4. Subjects with normal findings as determined by baseline history, physical examination, vital signs, Haemogram with ESR, Biochemistry, Infectious Disease Screening (HIV, Hepatitis B and Hepatitis C) and Urinalysis, ECG; 5. No drug abuser; 6. No alcoholic and smoking addiction; 7. Good communication with researchers and complied for requirements during the whole research work; 8. given a written informed- consent form and sign on the ICF.

Exclusion criteria

Exclusion criteria: 1. Participated in other clinical research within 3 months; 2. Had a history of blood donation within 1 month or intended to donate blood during the trial; 3. Failed in the general examination, blood pressure, heart rate and breath condition; 4. Any obvious clinical symptoms of disease founded during the medical examination; 5. laboratory evidence of hematology renal cardiac and hepatic abnormity.

Design outcomes

Primary

MeasureTime frame
The blood concentrations of sirolimus;

Countries

China

Contacts

Public ContactJianzhong Shen-Tu

First Affiliated Hospital, College of Medicine, Zhejiang University

stjz@zju.edu.cn+8 0571 87236560

Outcome results

None listed

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