Bioequivalence study.
Conditions
Interventions
Intervention 1: Intervention group 1: In this group, volunteers are given a single oral dose of Sertraline 100-mg tablets produced by Modava Co. (Domestic). In each period, 12 of 24 subjects will be g
Sponsors
Modava Pharmaceutical Company
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatima Molavi
Tabriz University of Medical Sciences
Outcome results
None listed