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IRCT20220209053979N10 IRCT 2023-06-18 Shafa Pharmaceutical Company Bioequivalence Study of Carvedilol 12.5 mg tablet manufactured by Shafa Pharmaceutical and Coreg manufactured by GSK Bioequivalence Study of Carvedilol 12.5 mg tablet manufactured by Shafa Pharmaceutical and Coreg manufactured by GSK in 24 Healthy Volunteers under fed condition 2023-06-30 anticipated 24 Complete https://irct.ir/trial/70057 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: Using the rand function of the Excel software, the candidates are divided into two groups, and half of them will receive numbers 1-12 and get the test drug, and the other half will receive numbers 13-24 and will take the reference drug, Blinding description: The tablets of Shafa pharmaceutical and GSK are both oval shape and white, so the candidate does not know which company's drug he will receive in each phase of the study. Additionally, the tubes of the volunteers' samples are also coded, so the analyzer does not know which company's drug he is analyzing, so only the researcher and the prescriber know which company's drug is being prescribed. Bioequivalence A crossover bioequivalence study in 24 healthy volunteers. Intervention 1: Intervention group: Oral administration of one tablet of Carvedilol 12.5 mg manufactured by Shafa Company to 12 healthy volunteers with 240 ml of water half an hour after eating breakfast. Then 17 blood samples are taken from each volunteers at certain time. Intervention 2: Intervention group: Oral administration of one tablet of Coreg 12.5 mg manufactured by GSK Company to 12 healthy volunteers with 240 ml of water half an hour after eating breakfast. Then 17 blood samples are taken from each volunteers at certain time. No - There is not a plan to make this available Justification or reason for not sharing IPD is The bioequivalence study data is completely confidential and according to the contract with Pharmachemi Company, it should not be published anywhere.
public Roya Talari
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
Islamshar Iran (Islamic Republic of) 3313679886 +98 21 5669 4726 talari_r@yahoo.com Kharazmi Plasma Center scientific Roya Talari
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
Islamshar Iran (Islamic Republic of) 3313679886 +98 21 5669 4726 talari_r@yahoo.com Kharazmi Plasma Center Iran (Islamic Republic of) Healthy male or female volunteers Body mass index (BMI) between 18 - 30 Volunteers who are willing to sign an informed consent form 18 years 55 years Both Familial history of heart disease History of allergy to Carvedilol or formulation components History or significant clinical evidence of any disease Taking any type of medicine in the 14 days before the start of the study Participation in any clinical study within 30 days prior to study initiation Systolic blood pressure less than 11 and diastolic less than 7 mmHg Treatment - Drugs Treatment - Drugs Intervention group: Oral administration of one tablet of Carvedilol 12.5 mg manufactured by Shafa Company to 12 healthy volunteers with 240 ml of water half an hour after eating breakfast. Then 17 blood samples are taken from each volunteers at certain time. Intervention group: Oral administration of one tablet of Coreg 12.5 mg manufactured by GSK Company to 12 healthy volunteers with 240 ml of water half an hour after eating breakfast. Then 17 blood samples are taken from each volunteers at certain time. Plasma concentration time profile, maximum plasma concentration, AUC. Timepoint: 0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 32 hours. Method of measurement: Liquid chromatography with mass spectrophotometry. Plasma concentration and then calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: 0, 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 24, 32 hours. Method of measurement: Plasma concentration is measured by Liquid chromatography with mass spectrometery and pharmacokientic parameters are calculated by excel. Shafa Pharmaceutical Company Approved 2023-06-14 Ethics Committee of Tehran University of Medical Science Tehran University of Medical Science, 16 Azar St., Tehran Tehran Iran (Islamic Republic of)