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IRCT20220209053979N6 IRCT 2023-02-10 Pars Darou Company Bioeqivalence study of escitalopram 10 mg tablet Bioequivalence Study of Escitalopram 10 mg of Pars Darou and Cipralex manufactured by Lundbeck in 24 Healthy Volunteers 2023-02-20 anticipated 24 Complete https://irct.ir/trial/67937 interventional Randomization: Randomized, Blinding: Double 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 Pars Darou and Lundbeck are both oval shaped and white 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 A crossover bioequivalence study in 24 healthy volunteers. Intervention 1: Intervention group: 1: Oral administration of two tablets of citalopram 10 mg manufactured by Pars Darou Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 17 blood samples are taken from each volunteers at certain time. In the second phase (two weeks later) this process is repeated vice verse. That is, these people will take Lundbeck's medicine and give blood samples at 17 time points. Intervention 2: Intervention group: 2: Oral administration of two tablets of citalopram 10 mg manufactured by Lundbeck Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 17 blood samples are taken from each volunteers at certain time. In the second phase (two weeks later) this process is repeated vice verse. That is, these people will take Pars Darou medicine and give blood samples at 17 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bioequivalence study data is completely confidential and according to the contract with Pars Darou Company, it should not be published anywhere.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) Laboratory tests +/- 10% of normal interval Without any history of chronic sickness 18 years 55 years Both History of medicine consumption Donation of blood sample more than 300 ml within last 30 days Treatment - Drugs Treatment - Drugs Intervention group: 1: Oral administration of two tablets of citalopram 10 mg manufactured by Pars Darou Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 17 blood samples are taken from each volunteers at certain time. In the second phase (two weeks later) this process is repeated vice verse. That is, these people will take Lundbeck's medicine and give blood samples at 17 time points Intervention group: 2: Oral administration of two tablets of citalopram 10 mg manufactured by Lundbeck Company to 12 healthy volunteers in fasting state with 240 ml of water. Then 17 blood samples are taken from each volunteers at certain time. In the second phase (two weeks later) this process is repeated vice verse. That is, these people will take Pars Darou medicine and give blood samples at 17 time points Plasma concentration time profile, Maximum plasma concentration, AUC. Timepoint: 0, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72, hours after drug administration. 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, 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72, hours after drug administration. Method of measurement: Plasma concentration is measured by Liquid chromatography with mass spectrometery and pharmacokientic parameters are calculated by excel. Pars Darou Company Approved 2023-02-07 Ethics Committee of Tehran University of Medical Science Tehran University of Medical Science, 16 Azar St., Tehran Tehran Iran (Islamic Republic of)