Bioequivalence of Sertraline 50 mg tablet manufactured by Shafa Pharmaceutical and Zoloft manufactured by Pfizer
Not Applicable
- Conditions
- A crossover bioequivalence study in 24 healthy volunteers.
- Registration Number
- IRCT20220209053979N9
- Lead Sponsor
- Shafa Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy male or female volunteers
Body mass index (BMI) between 18 - 30
Volunteers who are willing to sign an informed consent form
Exclusion Criteria
Familial history of heart disease
History of allergy to Sertraline or formulation components
Taking any type of medicine in the 14 days before the start of the study
Participation in any clinical study within 30 days prior to study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Plasma concentration time profile, maximum plasma concentration, AUC. Timepoint: 0, 1, 2, 3, 4, 4.5, 5, 6, 7, 8, 10, 24, 48, 72 hour after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry.
- Secondary Outcome Measures
Name Time Method Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: Same as primary outcome. Method of measurement: Pharmacokientic parameters are calculated by excel.