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IRCT20130603013572N5 IRCT 2020-09-07 Daana pharma.Co Bioequivalence Evaluation of Losartan and Cozaar® formulations in healthy volunteers Bioequivalence Evaluation of Losartan and Cozaar® formulations in healthy volunteers 2020-02-20 anticipated 26 Complete https://irct.ir/trial/45832 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention, Randomization description: Simple randomization administrating of test or reference product for each subject is determined according to the randomization schedule. The randomization schedule is prepared according to volunteer's allocated number. Each subject is identified by a number from 1 to 24 according to their entrance to volunteers' list in screening day. Randomly, Subjects with odd numbers receive the test drug and the subjects with even number receive the reference drug, Blinding description: Volunteers are blind in this study. The volunteers, according to the predetermined random table that is available to the researcher, are in one of the groups receiving the test or reference drug. Volunteers are aware that they are receiving the test drug (Iranian) and the reference drug (approved drug), but they do not know in which study period they will receive the test and reference drug. Bioequivalence Pharmacokinetics, Losartan , Bioequivalent. Intervention 1: Intervention group: 50 mg oral tablet of Losaratan (Dana pharmaceutical company), once daily. Intervention 2: Control group: 50 mg oral tablet of Cozaar ( merck), once daily. Yes - There is a plan to make this available What will be shared: Only protocol and methods of study are shareable When: Starting access 6 months after publication of data To whom: Pharmaceutical and medical sciences researchers Conditions: Using is not authorized Where to obtain: contact with E-mail of the main researcher How to obtain: Personal and academic details and the aim of data request. Comments:
public Dr. Mohammadreza Rouini
16 Azar street, Tehran university of medical sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) ۱۴۱۷۶۱۴۴۱۱ +98 21 6695 9056 rouini@tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammadreza Rouini
Tehran, 16 Azar St
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6695 9056 rouini@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) in healthy male and female volunteers 18 years 55 years Both History of hypersensitivity to the study drug or related products. Significant history or presence of gastrointestinal, kidney disease or any otherconditions known to interfere with the absorption, distribution, metabolism orexcretion of common medications. Significant history of asthma, chronic bronchitis or other bronchospasticcondition. Significant history or presence of glaucoma, cardiovascular or hematologicaldisease. Any clinically significant illness during the 4 weeks prior to day of this study. Maintenance therapy with any drug, or history of drug dependency, alcoholabuse, or serious neurological or psychological disease. Participation in a clinical trial with an investigation drug within 30 dayspreceding day 1 of this study. Use of enzyme- modifying drugs within 30 days prior to day 1 of this study. Use of any systemic medication (including OTC preparations) within 14 daysprior day 1 of this study. HIV and Hepatitis B and anti HCV antibody positive subjects. Smoking History of difficulty in donating blood Donation of blood within 90 days before first dosing. History of vaccination within one month before first dosing. Other Other Intervention group: 50 mg oral tablet of Losaratan (Dana pharmaceutical company), once daily Control group: 50 mg oral tablet of Cozaar ( merck), once daily Determination of drug concentration in blood plasma. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours after drug administration. Method of measurement: blood samples collection. Time to peak plasma concentration. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: observational. Maximum plasma concentration. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: observational. Area under the plasma concentration–time curves. Timepoint: 0 min and at 0.33, 0.66, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10 and 24 hours. Method of measurement: linear trapezoidal method. Daana pharma.Co Approved 2020-02-04 Vice-chancellor in research affairs- Tehran university of medical sciences Keshavarz Blvd., Tehran, Iran tehran Tehran Iran (Islamic Republic of)