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IRCT20180620040164N12 IRCT 2021-10-22 ACtover Pharmaceutical Co. Bioequivalence study of Domperidone 10 mg F.C. Tablet in 24 healthy male under fasting conditions Comparative bioequivalence study of Domperidone 10 mg F.C. Tablet of ACTOVERCO and Janssen Inc. in 24 healthy male under fasting 2020-06-12 anticipated 26 Complete https://irct.ir/trial/59218 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization schedule will be generated with the BEAR statistical software (Release V2.7.7). Each volunteer will be randomly assigned to one of the 2 different sequence of treatments according to the order of entering the study which will be allocated after screening. Bioequivalence Bioequivalence investigation of the generic Actover.Domperidone 10 mg F.C. Tablet with brand Motilium® Janssen capsule.. Intervention 1: Intervention group: Intervention group: (test): Domperidone 10 mg F.C. Tablet, produced by Actover is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention 2: Intervention group: Intervention group: Domperidone 10 mg F.C. Tablet, produced by Janssen is the test 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 should be between 18 – 45 years of age and their Body Mass Index (BMI) should be in the normal range according to the accepted average values between 18.5 and 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. Have a ECG and normal vital signs. Subjects who agree with the patient consent form. 18 years 45 years Male History of allergy or iosyncrasy to domperidone or any of the inactive components of the formulation. If you have or have a history of arrhythmia, including tachycardia or ventricular fibrillation, increased QT interval, bradycardia, or heart failure. Identify electrolyte disturbances and water loss due to diarrhea, vomiting or other causes 24 hours before the study. Bleeding or obstruction of the gastrointestinal tract during the last 6 weeks. In case of acute or chronic diseases related to the cardiovascular, respiratory, gastrointestinal, endocrine, blood and kidney or liver failure systems. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who have used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during the study period. History of alcohol or drug abuse within 5 years before the start of the study. Heavy drinker of caffeine, grapefruit juice, or caffeinated drinks or who are on a 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. Treatment - Drugs Treatment - Drugs Intervention group: Intervention group: (test): Domperidone 10 mg F.C. Tablet, produced by Actover is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention group: Intervention group: Domperidone 10 mg F.C. Tablet, produced by Janssen is the test 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 Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)