Bioequivalence study of Mirtazapine 30 mg
Not Applicable
Recruiting
- Conditions
- This study is performed on healthy volunteers and drug concentration in whole blood is determined..
- Registration Number
- IRCT20200623047902N39
- Lead Sponsor
- Actover Co
- 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
Alcoholism and Narcoticism
History of allergy to Mirtazapine
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Drug concentration in plasma. Timepoint: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 9, 12, 24, 36, 48, 72 hours after drug administration. Method of measurement: Liquid chromatography-MASS-MASS (LC- Mas/Mas).
- Secondary Outcome Measures
Name Time Method Time to reach maximum drug concentration in plasma. Timepoint: After intervention. Method of measurement: Time to reach the maximum drug concentration is recorded.;Extent of drug absorption. Timepoint: After intervention. Method of measurement: Calculation of area under curve of concentration -time.