Bioequivalence study of Everolimus 0.75mg tablet
Not Applicable
Recruiting
- Conditions
- This study is performed on healthy volunteers..
- Registration Number
- IRCT20200623047902N12
- Lead Sponsor
- Alborz Zagros company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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
Alcohol and drug addiction
History of allergy to Everolimus
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug plasma concentration. Timepoint: 0; 0.5; 1; 1.5;2; 2.5; 3; 4; 6; 8; 10; 12; 24; 48; 72h after drug administration. Method of measurement: Liquid Chromatography -MASS-MASS (LC-MASS/MASS).
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.