In- Vivo Bioequivalence study of Oxycodone tablet 40 mg Alborz Pharmed (LENITON® ER 40mg Tab.) with brand drugs (OLBETE® ER 40 mg Tab.,Purdue Pharma LP, UK) in Iranian healthy volunteers
Not Applicable
Recruiting
- Conditions
- Bio equivalence test.
- Registration Number
- IRCT20200105046010N69
- Lead Sponsor
- Alborz Pharmed Pharmaceutical 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? 0.5? 1? 1.5? 2? 2.5? 3? 3.5? 4? 4.5? 5? 6? 10 .8? 12 , 24 hours after prescribing the tablet. Method of measurement: High Performance Liquid Chromatography with tandem mass spectroscopy detector.
- Secondary Outcome Measures
Name Time Method