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IRCT20180620040164N11 IRCT 2021-10-20 Actover pharmaceutical co. Bioequivalence study of Metoprolol succinate 95 mg ER tablets in 24 healthy male under fasting conditions Randomized, single-dose, crossover comparative bioequivalence study of Metoprolol succinate 95 mg ER tablets of Actoverco and Recordati Pharma GmbH in 24 healthy male under fasting conditions 2020-12-04 anticipated 24 Complete https://irct.ir/trial/57629 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.) Metoprolol Succinate 95 mg tablet with brand Beloc-Zok® Recordati Pharma GmbH ER 95 mg tablet.. Intervention 1: Intervention group: Intervention group: (test): Metoprolol Succinate 95 mg tablet, produced by Actoverco. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention 2: Intervention group: (reference): Beloc-Zok 95 mg tablet, produced by Recordati Pharma GmbH. is the reference product. In each period, 12 of 24 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 – 40 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 vital signs. Subjects who agree with patient consent form. 18 years 40 years Male Known hypersensitivity or idiosyncratic reaction to Metoprolol succinate or inactive ingredients. History or current bronchial asthma. Subjects who has used any drug including prescription drugs (within 14 days) or Over-The-Counter (OTC) drugs within 7 days prior to the start of the study and might need drug intake during study period; History of alcohol or drug abuse A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: (test): Metoprolol Succinate 95 mg tablet, produced by Actoverco. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention group: (reference): Beloc-Zok 95 mg tablet, produced by Recordati Pharma GmbH. is the reference product. In each period, 12 of 24 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 2020-02-03 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)