enalidomide cap. 25mg Sobhan Oncology (LENASOB® 25mg), In-Vivo Bioequivalence in iranian healthy volunteer.
Not Applicable
Recruiting
- Conditions
- In this study, the disease is not examined. Subject bioequivalence test and reference tablets Teriflunomide studied..
- Registration Number
- IRCT20200105046010N26
- Lead Sponsor
- SOBHAN ONCOLOGY Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General health(liver, heart, kidney)
Body mass index(18-28)
Informed consent
Age(18-60)
Exclusion Criteria
Smoking
A history of cardiovascular disease
A history of liver & kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Determination of blood drug concentration. Timepoint: Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours After prescribing the tablet. Method of measurement: igh Performance Liquid Chromatography with tandem mass spectroscopy detector.
- Secondary Outcome Measures
Name Time Method