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General information
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Changing the name of laboratory for sampling and analysis
Changing the name of laboratory for sampling and analysis
empty
تغییر اسم آزمایشگاه نمونه گیری و آنالیز
تغییر اسم آزمایشگاه نمونه گیری و آنالیز
Recruitment centers
#1
Name of recruitment center - English: Simin Baspar Teyf Gostar Company
Name of recruitment center - Persian: شرکت سیمین بسپار طیف گستر
Full name of responsible person - English: Javad Shokri
Full name of responsible person - Persian: جواد شکری
Street address - English: No.48, Ferdos Street
Street address - Persian: خیابان فردوس، پلاک 48
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5167874434
Phone: +98 41 3384 2724
Fax:
Email: Shokri.j@gmail.com
Web page address:
Name of recruitment center - English: Dr. Shokri laboratory
Name of recruitment center - Persian: آزمایشگاه دکتر شکری
Full name of responsible person - English: Javad Shokri
Full name of responsible person - Persian: جواد شکری
Street address - English: No.48, Ferdos Street
Street address - Persian: خیابان فردوس، پلاک 48
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5167874434
Phone: +98 41 3384 2724
Fax:
Email: Shokri.j@gmail.com
Web page address:
Name of recruitment center - English: Simin Baspar Teyf Gostar CompanyDr. Shokri laboratory Name of recruitment center - Persian: شرکت سیمین بسپار طیف گسترآزمایشگاه دکتر شکری Full name of responsible person - English: Javad Shokri Full name of responsible person - Persian: جواد شکری Street address - English: No.48, Ferdos Street Street address - Persian: خیابان فردوس، پلاک 48 City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5167874434 Phone: +98 41 3384 2724 Fax: Email: Shokri.j@gmail.com Web page address:
Protocol summary
Study aim
Bioequivalence Study of Everolimus 0.75 mg manufactured by Alborz Zagros company versus originator brand (Certican) manufactured by Novartis company
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct
The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (72h). The interval between these two periods is 2 weeks. In the first round of the study, the candidates divide into two groups and the first group receives a test tablet and the second group receives a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcohol and drug addiction, History of allergy to Everolimus
Intervention groups
Intervention group 1: Certican 0.75mg tablet as a reference
Intervention group 2: Everolimus 0.75mg manufactured by Alborz zagros as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration, Half-life of drug
General information
Reason for update
Changing the name of laboratory for sampling and analysis
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047902N12
Registration date:2022-01-01, 1400/10/11
Registration timing:registered_while_recruiting
Last update:2025-06-29, 1404/04/08
Update count:1
Registration date
2022-01-01, 1400/10/11
Registrant information
Name
Elham Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 5196
Email address
ghasemian@zistdaru.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Everolimus 0.75mg manufactured by Alborz Zagros company versus originator brand in healthy volunteers in fasting condition
Public title
Bioequivalence study of Everolimus 0.75mg tablet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcohol and drug addiction
History of allergy to Everolimus
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
15
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. The balls are then removed randomly from the container. The first 12 no.s are considered as (first sequence: Alborz Zagros's medicine ) and the second 12 no.s are considered as (second sequence: originator brand recipient). The volunteers don't have any information about taking the test drug or brand drug
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Alborz Zagros's Everolimus and Originator brand's tablets are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.TBZMED.REC.1400.829
Health conditions studied
1
Description of health condition studied
This study is performed on healthy volunteers.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
0; 0.5; 1; 1.5;2; 2.5; 3; 4; 6; 8; 10; 12; 24; 48; 72h after drug administration
Method of measurement
Liquid Chromatography -MASS-MASS (LC-MASS/MASS)
Secondary outcomes
1
Description
Pharmacokinetic parameters
Timepoint
After intervention
Method of measurement
Theoretical and pahrmacokinetic equations
Intervention groups
1
Description
Intervention group: single dose, 2 oral tablet 0.75mg (Certican) manufactured by Novartis, as a reference product
Category
Treatment - Drugs
2
Description
Intervention group: Single dose, 2 oral tablet 0.75mg manufactured by Alborz Zagros company as test product
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shokri laboratory
Full name of responsible person
Javad Shokri
Street address
No.48, Ferdos Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Email
Shokri.j@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alborz Zagros company
Full name of responsible person
Amir Hossein Zolfaghari
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4163 7000
Email
A.zolfaghari@alborzzagros.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz Zagros company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visiting professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4163 7000
Email
Ghasemian_elham@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visiting professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4163 7000
Email
Ghasemian_elham@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visiting professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.58, 8th St. Kooye Nasr (Gisha St.)
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4163 7000
Email
ghasemian_elham@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
These data are secure between researchers and related industries.