In vivo Bioequivalence study of Sertraline 100 mg tablet manufactured by Reyhaneh Pharmaceutical Co. Compared to innovator Product Zoloft ®

In vivo Bioequivalence study of Sertraline 100 mg tablet manufactured by Reyhaneh Pharmaceutical Co. Compared to innovator Product Zoloft®

In the present study 24 healthy male volunteer will enter randomly as two groups of twelve people. For randomization, the rand function of Excel software will be used. Each volunteer will receive a single dose of drug in two periods. In one period the test formulation and in another period the reference formulation (as blinded). Therefore, each volunteer will be his own "Control".

After administration of single dose of formulation to healthy volunteers at the relevant place in Tabriz University of Medical Sciences, the blood samples (5 ml in each time point) will be taken in predetermined time intervals up to 72 hours. After plasma separation, the samples will be stored in freezer until analysis . In this study the volunteer would not be aware of the formulation identity in each period and the medicine is given to the patient outside of its original packaging.

Inclusion criteria: General Health (Liver, Heart and Kidney), Age (18-60) Exclusion criteria: Smoking, History of cardiovascular disease, liver and kidney disease, Pregnancy, Alcohol and drug addiction, History of drug allergy

Test group: Administrating the test product Control group: Administrating the innovator product In first period, one group of volunteers will receive single dose of test formulation (sertraline 100 mg tablet of Reyhaneh Pharmaceutical Co.) and the second group will receive a single dose of the reference formulation (Sertraline 100 mg tablet, Zoloft®) of same drug. After one week wash out period, by cross over design, the first group and second group will administer the reference and test formulations, respectively.

Drug plasma concentration

The order of receiving the test product or reference for each subject in each time period will be determined based on the randomization program. The randomization program will be developed using randomization software based on the number assigned to each subject. The number assigned to each subject will be based on the priority of being on the list of subjects for screening.

In this study, Volunteers participating will be blinded to the type of product they are taking in each period (test or reference product). In appearance, the two products are very similar and will be given to the volunteers for administration outside the original packaging.