Mood disorder due to known physiological condition with major depressive-like episode. Mood disorder due to known physiological condition with major depressive-like episode
Conditions
Interventions
Intervention 1: Intervention group 1:Escitalopram 20 mg F.C. Tablet , produced by Actoverco. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Afte
Sponsors
Actover Pharmaceutical Co.
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Healthy subjects (male) between 18 – 40 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2. Sitting blood pressure less than 100/ 60 mm Hg; Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects with normal ECG and vital signs. Subjects who agree with patient consent form.
Exclusion criteria
Exclusion criteria: Known hypersensitivity or idiosyncratic reaction to Escitalopram or inactive Allergy to any medication, substance, or food. History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, any kind of anemia, asthma, and mental disease. Muscular trauma 21 days before the beginning of the study. Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study and might need drug intake during study period. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. Subjects who have a history of alcohol or substance abuse within the last 5 years. Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity. A history of difficulty with donating blood or donation of more than 450 ml blood within 60 days prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 1, 2, 2/5, 3, 3/5, 4, 4/5, 5, 5/5, 6, 8, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC (Area Under the Concentration-Time Curve). Timepoint: 17 blood samples will be withdrawn pre-dose and at 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli aghaei
Noor Research & Development Institute
Outcome results
None listed