Bioequivalence study of erlotinib 150 mg
Not Applicable
- Conditions
- In this study, the disease is not examined. The subject of the study is the bioequivalence study of Erlotinib tablet 150 mg of test and reference in healthy volunteers..
- Registration Number
- IRCT20200623047902N6
- Lead Sponsor
- Zistdaru Danesh Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-60 years old)
Exclusion Criteria
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to erlotinib
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug plasma concentration. Timepoint: Before, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24, 36,48 and 72h after drug consumption. Method of measurement: HPLC -MASS-MASS.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters. Timepoint: After intervention. Method of measurement: Theoretical and pahrmacokinetic equations.