In-vivo Bioequivalence Test of Daclaasvir/Sofosbuvir 60/400 mg Actero Middle East with brand drug (Sofosbovir/Daclatasivir® 400/60 mg, Mylan, Germany)
Not Applicable
Recruiting
- Conditions
- Bio equivalence test.
- Registration Number
- IRCT20200105046010N68
- Lead Sponsor
- Actero middle east Pharm Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General health
Body mass index between18-28
Informed consent
Being at the age of 18-55 years old
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 Plasma drug concentration. Timepoint: Sampling times in this study will be ? 0.25? 0.5? 0.75? 1? 1.25? 1.5? 1.75? 2? 2.5? 3? 4? 6? 8? 10? 24 48 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.
- Secondary Outcome Measures
Name Time Method