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)
Synthesis of sodium zirconium cyclosilicate (SZC-9) drug by different methods and its in vitro comparison with the brand sample available in the market (Lokelma).
Design
A clinical trial with 2 parallel intervention groups and no control group, double-blind, phase 2, on 48 patients and randomized by using the website QuickCalcs.
Settings and conduct
This study will be conducted on two series of patient volunteers. The first group will receive a sample sachet (test) and the second group will receive a brand sachet. Blood samples are taken by the clinical supervisor immediately after taking the drug, and the sample preparation steps are performed on them to analyze the amount of analyte. This study will be conducted in Imam Reza Hospital, Tabriz.
Participants/Inclusion and exclusion criteria
Patients volunteers with hyperkalaemia, both sexes, ages ranged from 22 to 75 years, para-clinical health based on the tests performed, and no history of diseases affecting the digestive system.
Intervention groups
The intervention group received single-dose SZC-9 sachet formulated in this study and the control group received single-dose brand tablets (Lokelma®) manufactured by the company (AstraZeneca).
Main outcome variables
Level of blood potassium concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130313012810N11
Registration date:2023-07-15, 1402/04/24
Registration timing:prospective
Last update:2023-07-15, 1402/04/24
Update count:0
Registration date
2023-07-15, 1402/04/24
Registrant information
Name
Hamed Hamishehkar
Name of organization / entity
Drug Applied Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3311
Email address
hamishehkar.hamed@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-31, 1403/06/10
Expected recruitment end date
2024-10-31, 1403/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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)
Public title
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)
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
patients with hyperkalemia
Volunteers aged 22-75 years
male and female
Exclusion criteria:
History of diseases affecting the digestive system
Taking any medication at least 1 week before the start of the study
Age
From 22 years old to 75 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshghah St. Drug Applied Research Center
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2023-03-06, 1401/12/15
Ethics committee reference number
IR.TBZMED.REC.1401.1098
Health conditions studied
1
Description of health condition studied
Hyperkalaemia
ICD-10 code
E87.5
ICD-10 code description
Hyperkalaemia
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
N/A
2
Description
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
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Drug Applied Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Research and Technology Vice-Chancellor., Central Building No. 2., 3rd Floor.,Tabriz University of Medical Sciences., Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165990001
Phone
+98 41 3336 4664
Email
shahabip@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available