Bioequivalence study of Sirolimus 1mg tablet
Not Applicable
- Conditions
- This study is performed on healthy volunteers and drug concentration in whole blood is determined..
- Registration Number
- IRCT20200623047902N11
- Lead Sponsor
- Alborz Zagros company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)
Exclusion Criteria
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to Sirolimus
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentration in blood. Timepoint: 0; 0.33, 0.66; 1; 1.33; 1.66, 2; 3; 4; 6; 8; 10; 12; 24; 48; 72h after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas.
- Secondary Outcome Measures
Name Time Method Time to reach maximum blood concentration. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration is recorded.;Extent of absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.