Bioequivalence study of Quetiapine 100 mg tablet
Not Applicable
- Conditions
- In the present study, no diseases will be examined and products will be administered by healthy volunteers..
- Registration Number
- IRCT20210519051345N5
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
General Health (Liver, Heart and Kidney)
Age (20-60)
Exclusion Criteria
Smoking,
history of cardiovascular disease, history of liver and kidney disease,
pregnancy,
alcohol and drug addiction
history of drug allergy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma Drug Concentration. Timepoint: 0.5-24 hours in predetermined time intervals after drug administration. Method of measurement: HPLC.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What pharmacokinetic and pharmacodynamic profiles were assessed in the IRCT20210519051345N5 Quetiapine 100 mg bioequivalence study?
How does the bioavailability of Fatak Shimi's Quetiapine 100 mg compare to the innovator product in the IRCT20210519051345N5 trial?
Which pharmacogenetic biomarkers influence Quetiapine metabolism in the IRCT20210519051345N5 bioequivalence study?
What adverse events were observed in healthy volunteers during IRCT20210519051345N5 Quetiapine bioequivalence testing?
How do CYP3A4 and CYP2D6 enzyme activities impact Quetiapine bioequivalence in the IRCT20210519051345N5 study?