]>
IRCT20130313012810N11 IRCT 2023-07-15 Tabriz University of Medical Sciences Comparative bioequivalence study of sodium zirconium cyclosilicate (SZC-9) in the forms of 5 and 10 g sachets vs brand medicine (Lokelma made by AztraZeneca) Comparative bioequivalence study of sodium zirconium cyclosilicate (SZC-9) in the forms of 5 and 10 g sachets vs brand medicine (Lokelma made by AztraZeneca) 2024-08-31 anticipated 24 Complete https://irct.ir/trial/70908 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Web-based randomization is used by using the website http://www.graphpad.com/quickcalcs/index.cfm Candidates will be given codes 1 to 48 in the order of entering the study, so that when the selection of candidates begins, the first person who enters the study will have code 1 and the last candidate who enters the study will have code 48. Then the following steps will be done on the site: Random numbers>>>Randomly assign subjects to groups>>>Randomly choose a group for each subject. And finally, two groups A and B will be randomly composed of 24 volunteers each, Blinding description: In this study, the volunteers participating in the study and the clinical supervisor are blinded to the type of product consumed at each time of the study (test or reference product). That is, the product outside the original packaging will be given to the volunteer by the researcher for consumption. Bioequivalence Hyperkalaemia. Intervention 1: Intervention group 1: Candidates will receive 10 grams of powder (sachet) of the test drug and blood will be taken 48 hours after receiving the drug. Intervention 2: Intervention group 2: Candidates will receive 10 grams of powder (sachet) of the brand drug and blood will be taken 48 hours after receiving the drug. 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 After the end of the study, if the data is suitable, it will be announced in the form of an article
public Hamed Hamishehkar
Drug Applied Research Center, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 3336 3181 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences scientific Hamed Hamishehkar
Drug Applied Research Center, Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 51656-65811 +98 41 3336 3181 hamishehkar.hamed@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) patients with hyperkalemia Volunteers aged 22-75 years male and female 22 years 75 years Both History of diseases affecting the digestive system Taking any medication at least 1 week before the start of the study E87.5 Hyperkalaemia N/A N/A Intervention group 1: Candidates will receive 10 grams of powder (sachet) of the test drug and blood will be taken 48 hours after receiving the drug Intervention group 2: Candidates will receive 10 grams of powder (sachet) of the brand drug and blood will be taken 48 hours after receiving the drug Plasma concentration of potassium. Timepoint: Measurement of blood potassium at the beginning of the study (before the start of the intervention), 2, 6, 12, 24, 36, and 48 hours after receiving the drug by the patients. Method of measurement: Biorexfars potassium kit. Tabriz University of Medical Sciences Approved 2023-03-06 Ethics committee of Tabriz University of Medical Sciences Daneshghah St. Drug Applied Research Center Tabriz East Azarbaijan Iran (Islamic Republic of)