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IRCT20180620040164N39 IRCT 2023-01-23 Actover Pharmaceutical Co. Comparative in vivo evaluation of 2 Escitalopram 20 mg F.C. Tablet formulations. Comparative bioequivalence study of Escitalopram 20 mg F.C. Tablet of Actoverco. and Cipralex of Lundbeck Limited as reference in 24 healthy male under fasting. 2023-02-10 anticipated 24 Complete https://irct.ir/trial/68141 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer numbers (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer. Bioequivalence Mood disorder due to known physiological condition with major depressive-like episode. 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. After 14-day wash-out period the intervention 2 will be given to these subjects. Intervention 2: Intervention group 2: Cipralex 20 mg tablet, produced by Boehringer is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-day wash-out period the intervention 1 will be given to these subjects. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It's undetermind yet.
public Ali aghaei
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Noor Research & Development Institute scientific Seyed Mohsen Foroutan
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 mforoutan@gmail.com Tavan Institute Iran (Islamic Republic of) 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. 18 years 40 years Male 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. F06.32 Mood disorder due to known physiological condition with major depressive-like episode Treatment - Drugs Treatment - Drugs 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. After 14-day wash-out period the intervention 2 will be given to these subjects. Intervention group 2: Cipralex 20 mg tablet, produced by Boehringer is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-day wash-out period the intervention 1 will be given to these subjects. 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). 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). Actover Pharmaceutical Co. Approved 2023-01-10 Ethics Committee,School of Pharmacy,Nursing&Midwifery-Shahid Beheshti University of medical sciences Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)