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IRCT20180620040164N5 IRCT 2021-01-05 Actover pharmaceutical co. bioequivalence study of Escitalopram 10 mg film-coated tablets in 18 healthy male under fasting conditions Randomized, single-dose, crossover comparative bioequivalence study of Escitalopram 10 mg film-coated tablets of Actoverco. and Lundbeck Limited Co. in 18 healthy male under fasting conditions 2019-11-30 anticipated 18 Complete https://irct.ir/trial/52433 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization schedule is generated with the BEAR statistical software (Release V2.7.7). Each volunteer is randomly assigned to one of the 2 different sequence of treatments according to their entrance number to study which is allocated after screening. Bioequivalence Bioequivalence investigation of the generic (Actoverco.) Escitalopram 10 mg tablet with brand (Cipralex ) Lundbeck Limited 10 mg tablet.. Intervention 1: Intervention group: (test): Escitalipram 10 mg tablet, produced by Actoverco. is the test product. In each period, 9 of 18 subjects will be given single oral dose of this product. Intervention 2: Control group: (reference): Cipralex® 10 mg tablet, produced by Lundbeck Limited co. is the reference product. In each period, 9 of 18 subjects will be given single oral dose of this product. No - There is not a plan to make this available Justification or reason for not sharing IPD is It's not specified yet
public Ali Aghaei
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., 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, Hosseini Squ., Teymoury St., Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 info@tavaninstitute.ir Tavan Institute Iran (Islamic Republic of) Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5-30 (inclusive), calculated as kg/m2. 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 45 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. Subjects who have a history of alcohol or substance abuse within the last 5 years Treatment - Drugs Treatment - Drugs Intervention group: (test): Escitalipram 10 mg tablet, produced by Actoverco. is the test product. In each period, 9 of 18 subjects will be given single oral dose of this product. Control group: (reference): Cipralex® 10 mg tablet, produced by Lundbeck Limited co. is the reference product. In each period, 9 of 18 subjects will be given single oral dose of this product. Peak Plasma Concentration (Cmax). Timepoint: During 2 months 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: During 2 months 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 2019-10-07 Ethics committee of Shahid Beheshti University of Medical Sciences Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht Tehran Tehran Iran (Islamic Republic of)