Bioequivalence study of sertraline hydrochloride 50 and 100 mg tablets under fasting conditions

Not Applicable

• Conditions: Antidepressant drugs.; Healthy volunteers

• Registration Number: IRCT2016022813776N3
• Lead Sponsor: Sobhandarou Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 24

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drug plasma concentration. Timepoint: After intervention. Method of measurement: Blood sampling.

Secondary Outcome Measures

Name	Time	Method
Time to reach Cmax. Timepoint: After intervention. Method of measurement: Blood sampling.