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IRCT20180620040164N49 IRCT 2023-09-11 Actover Pharmaceutical Co. Comparative in vivo evaluation of 2 Mesalazine 500 mg ER Capsule and PENTASA® 500 mg ER Tablet formulations. Comparative bioequivalence study of Mesalazine 500 mg ER Capsule of ActoverCo. and PENTASA®of Ferring as reference in 24 healthy male under fasting condition 2023-09-06 anticipated 24 Complete https://irct.ir/trial/70578 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 Ulcerative colitis. Intervention 1: Intervention group 1: Mesalazine 500 mg ER Capsule , produced by Karen. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-day wash-out period the intervention 2 will be given to these subjects. Intervention 2: Intervention group 2: Mesalazine 500 mg ER Capsule (PENTASA®), produced by Ferring is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-day wash-out period the intervention 1 will be given to these subjects. 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 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 info@tavaninstitute.ir Noor Research & Development Institute scientific Seyed Mohsen Foroutan
No-Avari Sharif 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. 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 normal vital signs. Subjects who agree with patient consent form. 20 years 45 years Male Subjects with clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations Subjects with known allergy to the products tested or NSAIDs. Significant clinical illness within 3 weeks prior to screening. History of GI surgery or any other surgery within the past 3 months. History of any significant disease that jeopardize safety of the subject or validity of test results. History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study. Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period. History of alcohol or drug abuse. 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 K51 Ulcerative colitis Treatment - Drugs Treatment - Drugs Intervention group 1: Mesalazine 500 mg ER Capsule , produced by Karen. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-day wash-out period the intervention 2 will be given to these subjects. Intervention group 2: Mesalazine 500 mg ER Capsule (PENTASA®), produced by Ferring is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 14-day wash-out period the intervention 1 will be given to these subjects. Peak Plasma Concentration (Cmax). Timepoint: 14 blood samples will be withdrawn pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 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: 14 blood samples will be withdrawn pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 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). Actover Pharmaceutical Co. Approved 2020-03-02 Ethics Committee,School of Pharmacy,Nursing&Midwifery; Shahid Beheshti University of medical science Niayesh Highway, Valiasr Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)