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IRCT20180620040164N18 IRCT 2022-01-08 Karen Pharma and Food Supplement Co. Bioequivalence study of Valsartan 160 mg tablet in 24 healthy male under fasting conditions Comparative bioequivalence study of Valsartan 160 mg tablet of Karen Pharma and Food Supplement Co. and Novartis pharmaceuticals. 2022-01-20 anticipated 24 Complete https://irct.ir/trial/61028 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 Karen Pharma and Food Supplement Co. Valsartan 160 mg tablet with brand Diovan® 160 mg tablet Novartis pharmaceuticals... Intervention 1: Intervention group: (test): Valsartan 160 mg Tablet, produced by Karen Pharma and Food Supplement Co. 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):Diovan® 160 mg Tablet, produced by Novartis pharmaceuticals 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 candidates should be between 18-40 years old and their BMI should be in the range (Kg/m2) 18.5-30. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects must have normal vital signs. Sitting systolic blood pressure is in the range of 110-120 mm Hg and diastolic blood pressure is in the range of 70-80 mm Hg and heart rate is 60-90 beats per minute. Subjects who agree with patient consent form. 18 years 45 years Male History of known allergies to valsartan, new drugs or any of the inactive components of the formulation; A history of liver or gastrointestinal disease that may interfere with the absorption, distribution, metabolism, or excretion of the drug; History of liver or kidney disease Smokers who smoke more than 10 cigarettes a day and have trouble not smoking during each clinical study period. History of anaphylaxis or angioedema History of bleeding or coagulation problems People who have taken over-the-counter or prescription drugs 7 days before the start of the first period will need to take the drug at the same time during the study. People with a history of alcohol or drug addiction Subjects who consume heavy caffeinated beverages, fruit juices (grapefruit juice) either follow a special diet (vegetarian) or do strenuous physical activity. History of difficulty donating blood or donating more than 500 ml of blood in less than seven days before the start of the study. Treatment - Drugs Treatment - Drugs Intervention group: (test): Valsartan 160 mg Tablet, produced by Karen Pharma and Food Supplement Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. Intervention group: (reference):Diovan® 160 mg Tablet, produced by Novartis pharmaceuticals 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). Karen Pharma and Food Supplement Co. Approved 2021-09-21 Ethics committee of Shahid Beheshti University of Medical Sciences Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)