Bioequivalence Study of Sertraline 50 mg tablet manufactured by Shafa Pharmaceutical and Zoloft manufactured by Pfizer in 24 Healthy Volunteers under fasting condition

Bioequivalence of Sertraline tablets of Shafa Pharmaceutical company with Zoloft tablets of Pfizer company ( Germany)

Bioequivalence study, Cross over, Double blinded. Randomization is done by Rand function of Excel software.

Sampling of volunteers is done in Kharazmi Plasma Center in Islamshahr. On the day of sampling, one 40 mg tablet of Sertraliine manufactured by Shafa or Pfizer on two occasions and with a washout period of 14 days, will be administered orally with 240 ml of water to the volunteer. For example, if in the first phase he received the medicine made by Shafa company, he will receive the brand medicine two weeks later. In each phase, 5 cc of blood sample will be taken before drug administration and at times 0, 1, 2, 3, 4, 4.5, 5, 6, 7, 8, 10, 24, 48 and 72 hours after prescribing the medicine. Two weeks after the start of the study, the volunteer's cooperation in this research ends. The way to cooperate in these two weeks is that the drug is prescribed in the first day and after that 72 hours blood sampling is done at the mentioned times after washout period of two weeks the other drug is administered and blood samples will be taken at the same time.

Inclusion criteria: Healthy male or female volunteers between the ages of 18 and 55 with a body mass index (BMI) between 19 and 30 - People who are willing to sign an informed consent form. Exclusion criteria: history of heart disease

First group: 12 people who take Shafa pharmaceutical tablets The second group: 12 people who take Pfizer pills on the same day

Plasma concentration and area under the curve of plasma concentration time of test and reference drug

Using the rand option of the Excel software, the candidates are divided into two groups, and half of them will receive numbers 1-12 and get the test drug, and the other half will receive numbers 13-24 and will take the reference drug.

Before prescribing the medicine, the pills are removed from the blister by the prescriber, so the volunteer does not know which company's medicine is taking. Additionally, the tubes of the volunteers' samples are also coded, so the analyzer does not know which company's drug he is analyzing, so only the researcher and the prescriber know which company's drug is being prescribed.

The bioequivalence study data is completely confidential and according to the contract with Shafa Pharmaceutical Company, it should not be published anywhere.