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IRCT20180620040164N30 IRCT 2022-06-13 Cosar pharmaceutical Co. Comparative in vivo evaluation of 2 Levodopa/Benserazide 200/50 mg Tablet formulations. Comparative bioequivalence study of Levodopa/Benserazide 200/50 mg tablet of Cosar pharmaceutical Co. and Madopar 250 mg tablet of Roche as reference in 24 healthy male under fasting. 2022-06-22 anticipated 24 Complete https://irct.ir/trial/64091 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer's number (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer. Bioequivalence parkinson's disease. Intervention 1: Intervention group 1: Levodopa/Benserazide 200/50 mg tablet , produced by Cosar pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 2 will be given to these subjects. Intervention 2: Intervention group 2: Madopar 250 mg tablet, produced by Roche is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 1 will be given to these subjects. No - There is not a plan to make this available Justification or reason for not sharing IPD is It's undetermind yet.
public Ali Aghaei
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 partochem@gmail.com Noor Research & Development Institute scientific Seyed Mohsen Foroutan
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 mforoutan@gmail.com 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 between 18.5 - 30 kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Subjects that have normal vital signs. Subjects who agree with patient consent form. 20 years 45 years Male Subjects with known allergy to the products tested. History of cardiovascular, hepatic, renal, psychiatric, neurologic, hematologic, or metabolic disease 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 14 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. G20 Parkinson's disease Treatment - Drugs Treatment - Drugs Intervention group 1: Levodopa/Benserazide 200/50 mg tablet , produced by Cosar pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 2 will be given to these subjects. Intervention group 2: Madopar 250 mg tablet, produced by Roche is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 1 will be given to these subjects. Peak Plasma Concentration (Cmax). Timepoint: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24, 48 and 72 hours 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: 17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 24, 48 and 72 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). Cosar pharmaceutical Co. Approved 2021-07-20 Ethics Committee of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Medica Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)