Antidepressant drugs. Healthy volunteers
Conditions
Interventions
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
Treatment - Drugs
Single dose of one Zoloft (sertraline) 100 mg tablet manufactured by Pfizer
Single dose of two sertraline 50 mg tablets (100 mg) manufactured by Sobhandarou
Single dose of one sertraline 100 mg tablet manufactured by Sobhandarou
Sponsors
Sobhandarou Pharmaceutical Company
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug plasma concentration. Timepoint: After intervention. Method of measurement: Blood sampling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach Cmax. Timepoint: After intervention. Method of measurement: Blood sampling. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Hossein Amini
Gorgan Bioanalysis Center
Outcome results
None listed