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IRCT2016022813776N3 IRCT 2016-12-27 Sobhandarou Pharmaceutical Company Bioequivalence study of sertraline hydrochloride 50 and 100 mg tablets under fasting conditions A study to compare the relative bioavailability of Sobhandarou and Pfizer formulations of sertraline 50 and 100 mg tablets in 24 healthy adult male volunteers under fasting conditions 2016-11-25 anticipated 24 Complete https://irct.ir/trial/13557 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Health service research. Bioequivalence Antidepressant drugs. Intervention 1: Single dose of two sertraline 50 mg tablets (100 mg) manufactured by Sobhandarou. Intervention 2: Single dose of one sertraline 100 mg tablet manufactured by Sobhandarou. Intervention 3: Single dose of one Zoloft (sertraline) 100 mg tablet manufactured by Pfizer.
public Dr. Hossein Amini
Golshahr Bolv., Golshahr 14, Aftabgardan Bulding, No. 6
Gorgan Iran (Islamic Republic of) +98 17 3252 5972 haminhplc@yahoo.com Gorgan Bioanalysis Center scientific Dr. Hossein Amini
University Main Campus
Gorgan Iran (Islamic Republic of) +98 17 3252 5972 haminhplc@yahoo.com Golestan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Males, 18-50 years of age (inclusive). 2. The subject is able and willing to provide written informed consent. 3. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. 4. The subject has stable residence and telephone. 5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. Exclusion criteria: 1. History of allergy or sensitivity to sertraline hydrochloride or other selective serotonin reuptake inhibitor's (SSRI's), or history of any drug hypersensitivity or intolerance which, in the opinion of the investigator, would compromise the safety of the subject or the study. 2. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. 3. Presence of gastrointestinal disease or history of malabsorption within the last year. 4. History of psychiatric disorders occurring within the last two years that required hospitalization or medication. 5. Presence of a medical condition requiring regular treatment with prescription drugs. 6. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. 7. Use within 7 days of dosing, or anticipated use during the study, or for 7 days after the last dose of sertraline any monoamine oxidase inhibitors (MAOIs). 8. Receipt of any drug as part of a research study within 30 days prior to dosing. 9. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to dosing. 18 years 50 years Male F32 Healthy volunteers Treatment - Drugs Treatment - Drugs Treatment - Drugs Single dose of two sertraline 50 mg tablets (100 mg) manufactured by Sobhandarou Single dose of one sertraline 100 mg tablet manufactured by Sobhandarou Single dose of one Zoloft (sertraline) 100 mg tablet manufactured by Pfizer Drug plasma concentration. Timepoint: After intervention. Method of measurement: Blood sampling. Time to reach Cmax. Timepoint: After intervention. Method of measurement: Blood sampling. Sobhandarou Pharmaceutical Company Approved 2016-01-21 Golestan University of Medical Sciences Gorgan, Km 2 Sari Road Gorgan Iran (Islamic Republic of)