]>
IRCT20220209053979N5 IRCT 2023-02-04 Alborz Darou Bioeqivalence study of amlodipine valsartan 10/160 mg tablet هم ارزی زیستی Bioequivalence Study of amlodipine valsartan 10/160 mg manufactured by Alborz Darou and Exforge manufactured by Novartis in 24 Healthy Volunteers 2023-02-23 anticipated 24 Complete https://irct.ir/trial/68016 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other, Randomization description: Using the rand option of the Excel software, the candidates are divided into two groups, and half of them will receive numbers 1-12 and the test drug, and the other half will receive numbers 13-24 and will receive the reference drug, Blinding description: The tablets of Alborz Daru and Novartis are both oval shaped and pink in color, so the candidate does not know which company's drug he will receive in each phase of the study. On the other hand, 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 Bioequivalence study. Intervention 1: Intervention group: 1 oral administration of one amlodipine valsartan 10/160 mg tablet manufactured by Alborz Daru Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at certain intervals. In the second phase (two weeks later) this process is repeated in reverse. This means that these people take Novartis medicine and give blood samples at 16 time points. Intervention 2: Intervention group 2: Oral administration of a 160/10 amlodipine valsartan tablet manufactured by Novartis to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at certain intervals. In the second phase (two weeks later) this process is repeated in reverse. This means that these people take Alborz Daru's medicine and give blood samples at 16 time points. 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bioequivalence study data is completely confidential and according to the contract with Alborz Daru Company, it should not be published anywhere.
public Roya Talari
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
Tehran 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,
Tehran Iran (Islamic Republic of) 3313679886 +98 21 5669 4726 talari_r@yahoo.com Kharazmi Plasma Center Iran (Islamic Republic of) Laboratory tests +/- 10% of normal interval without any history of chronic sickness 18 years 55 years Both Systolic blood pressure less than 90 and diastolic less than 60 mm Hg Smoking more than 10 cigarette per day Treatment - Drugs Treatment - Drugs Intervention group: 1 oral administration of one amlodipine valsartan 10/160 mg tablet manufactured by Alborz Daru Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at certain intervals. In the second phase (two weeks later) this process is repeated in reverse. This means that these people take Novartis medicine and give blood samples at 16 time points Intervention group 2: Oral administration of a 160/10 amlodipine valsartan tablet manufactured by Novartis to 12 healthy volunteers in fasting state with 240 ml of water. Then 16 blood samples are taken from the volunteers at certain intervals. In the second phase (two weeks later) this process is repeated in reverse. This means that these people take Alborz Daru's medicine and give blood samples at 16 time points Plasma concentration time profile,. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry. Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 6, 8, 10, 12, 24 and 32 hours after drug administration. Method of measurement: Pharmacokientic parameters are calculated by excel. Alborz Darou Approved 2023-01-30 Ethics Committee of Tehran University of Medical Science Tehran University of Medical Science, 16 Azar St., Tehran Tehran Iran (Islamic Republic of)