Study of absorption and elimination rate of Sertraline 100-mg tablets in comparison with Sertraline brand tablets (Zoloft®).

Not Applicable

• Conditions: Bioequivalence study.

• Registration Number: IRCT20200407046981N46
• Lead Sponsor: Modava Pharmaceutical Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

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

Inclusion Criteria

Healthy male volunteers in the age range of 18-60 years old
The weight limit of each volunteer should be between 60 and 100 kg.
Body mass index should be between18-30
All volunteers must be non-smokers
They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed
Candidates who have consented to the consent form

Exclusion Criteria

Known hypersensitivity or idiosyncratic reaction to Sertralin or any ingredients.
Subjects with BP = 90/60 mm/Hg or BP = 140/90 mm/Hg.
Taking any medicine during two week before dosing.
Any effects of renal, hepatic, cardiac, pulmonary or gastrointestinal dysfunction
Any history of tuberculosis, seizures, asthma, diabetes, insanity or glaucoma

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax). Timepoint: 0 (before dosing), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours after dosing. Method of measurement: High-performance liquid chromatography—mass spectrometry (HPLC-MS).

Secondary Outcome Measures

Name	Time	Method
AUC (Area Under the Concentration-Time Curve). Timepoint: 0 (before dosing), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 and 72 hours after dosing. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS.