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IRCT20180620040164N35 IRCT 2022-11-16 Actover Pharmaceutical Co. Bioequivalence study of Betahistine 16 mg tablet in 24 healthy male under fasting conditions Comparative bioequivalence study of Betahistine 16 mg tablet of ACTOVERCO and Abbott in 24 healthy male under fasting 2022-04-03 anticipated 24 Complete https://irct.ir/trial/62299 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. Betahistine 16 mg tablet with brand Betaserc® Abbott Tablet.. Intervention 1: Intervention group: (test): Betahistine 16 mg 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: Betahistine 16 mg tablet produced by Abbott is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. 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 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 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal 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. Subjects with normal vital signs. Subjects who agree with patient consent form. 20 years 45 years Male Subjects with known allergy to the products tested. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. Subjects who has used any drug including prescription 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 within 2 years before the start of the study. Heavy drinker of caffeine, 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 500 ml blood within 7 days prior to the start of the study. Treatment - Drugs Treatment - Drugs Intervention group: (test): Betahistine 16 mg 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: Betahistine 16 mg tablet produced by Abbott 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 2021-03-07 Ethics committee of Shahid Beheshti University of Medical Sciences Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)