A crossover bioequivalence study in 24 healthy volunteers.
Conditions
Interventions
Intervention 1: Intervention group: Oral administration of one tablet of Sertraline 50 mg manufactured by Shafa Company to 12 healthy volunteers under fasting condition with 240 ml of water. Then 14 b
Sponsors
Shafa Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactRoya Talari
Kharazmi Plasma Center
Outcome results
None listed