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IRCT20180620040164N54 IRCT 2024-01-22 Zist Arvand Pharme Ltd. Comparative in vivo evaluation of 2 Ticagrelor 90 mg F.C. Tablet and Brilinta® 90 mg F.C. Tablet formulations. Comparative bioequivalence study of Ticagrelor 90 mg F.C. Tablet of Zist Arvand Pharmed. and Brilinta®of Asterazeneca Sciences as reference in 24 healthy male under fasting condition 2024-04-20 anticipated 24 Complete https://irct.ir/trial/75081 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 numbers (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 Long term (current) use of antithrombotics/antiplatelets. Intervention 1: Intervention group 1 (Test): Ticagrelor 90 mg F.C. Tablet , produced by Zist arvand Pharmed. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 2 will be given to these subjects. Intervention 2: Intervention group 2 (refrence): Ticagrelor 90 mg F.C. Tablet (Brilinta®), produced by Asterazeneca is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-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 Behzad Montaha Sangari
Sharif Innovation Station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
Tehran Iran (Islamic Republic of) 1459926609 +98 21 6600 4027 Behzad_first@yahoo.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 18 – 45 years of age. Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18 and 27 (inclusive), calculated as kg/m2. Subjects with no significant diseases or abnormal findings during laboratory evaluations and clinical examination. Subjects with normal vital signs. 18 years 45 years Male Subjects with known allergy to the products tested. volunteers with associated acute or chronic infections. Personal history of vascular abnormality such as aneurysm, thrombocytopenia, peptic ulcer and platelet count less than 109*150/liter. heart rate less than 60 per minute. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. 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. Z79.02 Long term (current) use of antithrombotics/antiplatelets Treatment - Drugs Treatment - Drugs Intervention group 1 (Test): Ticagrelor 90 mg F.C. Tablet , produced by Zist arvand Pharmed. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 2 will be given to these subjects. Intervention group 2 (refrence): Ticagrelor 90 mg F.C. Tablet (Brilinta®), produced by Asterazeneca is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 1 will be given to these subjects. Peak Plasma Concentration (Cmax). Timepoint: 18 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 and 48 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: 18 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.33, 1.67, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 and 48 hours after intervention. Method of measurement: Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA). Zist Arvand Pharme Ltd. Approved 2024-01-15 Ethics committee of Shahid Beheshti University of Medical Sciences Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)