In- Vivo Bioequivalence study of Abiraterone tablet 250 mg Sobhan Oncology Pharma (Abiraterone ® 250 mg Tab.) with brand drug (ZYTIGA® 250 mg, Janssen Biotech, Germany) in Iranian healthy volunteers.
In- Vivo Bioequivalence study of Abiraterone tablet250 mg Sobhan Oncology Pharma with brand drug (ZYTIGA® 500 mg, Janssen Biotech, Germany) in Iranian healthy volunteers.
Design
In-vivo bioequivalence study of Abiraterone tablet 250 mg Sobhan Oncology Pharma in comparison with reference drug (ZYTIGA® 250 mg, Janssen Biotech, Germany). The single blind, Cross-over, two period, two groups (Intervention and control) and randomized (paper lottery randomization method) study with one week wash-out time.
Settings and conduct
This study is carried out in Simin Baspar Tayf-Gostar Company, Tabriz, Iran. The study population is 24 healthy Iranian volunteers.This study is a single blind study and by taking out the drugs from the existing packaging, the volunteers will not know the time of receiving the test drug and the brand. This study is a cross over study that is performed in two time periods of 72 hours with a two-week wash-out period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-55 years old; body mass index (BMI) in the range of 18-28. Exclusion criteria: history of heart; kidney and liver disease; pregnancy; drug addiction; smoking
Intervention groups
Single dose Abiraterone tablet 250 mg Sobhan Oncology Pharma. Control group: brand drugs (ZYTIGA® 250 mg, Janssen Biotech, Germany)
Main outcome variables
Plasma drug concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N59
Registration date:2022-04-18, 1401/01/29
Registration timing:registered_while_recruiting
Last update:2022-04-18, 1401/01/29
Update count:0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Javad Shokri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3661 4125
Email address
shokri.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-27, 1401/01/07
Expected recruitment end date
2022-10-02, 1401/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Abiraterone tablet 250 mg Sobhan Oncology Pharma (Abiraterone ® 250 mg Tab.) with brand drug (ZYTIGA® 250 mg, Janssen Biotech, Germany) in Iranian healthy volunteers.
Public title
In-vivo Bioequivalence Test of Abiraterone tablet 250 mg Sobhan Oncology with brand drug (ZYTIGA® 500 mg, Janssen Biotech, Germany)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health
Body mass index between18-28
Informed consent
Being at the age of 18-60 years old
Exclusion criteria:
Smoking
A history of cardiovascular disease
A history of liver & kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Age
From 18 years old to 60 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, A 24- persons group will be selected and divided to two 12-persons groups randomly. The names of all volunteers will be written on paper pieces and wrapped in aluminum foils. The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Candidates are not aware of receiving the test drug or brand one. In a one-blind study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Test and Brand drugs 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 drug.
Placebo
Not used
Assignment
Crossover
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
Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-03-01, 1399/12/11
Ethics committee reference number
IR.TBZMED.REC.1399.1150
Health conditions studied
1
Description of health condition studied
Bio equivalence test
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma drug concentration
Timepoint
Sampling times in this study will be 0, 0:30, 1, 1:30, 2, 2:30, 3, 3:5, 4, 6, 8, 10, 24, 48, 72 hours after prescribing the tablet.
Method of measurement
High Performance Liquid Chromatography with tandem mass spectroscopy detector
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One test tablet (Abiraterone tablet 250 mg produced by Sobhan Oncology Pharma) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector
Category
Treatment - Other
2
Description
Control group: One Reference tablet ZYTIGA® 250 mg, Janssen Biotech, Germany will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of drug in plasma samples will be measured by liquid chromatography with mass spectroscopy detector
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Simin Baspar Teyf Gostar Company
Full name of responsible person
Javad Shokri
Street address
No.48, Ferdos square
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
Sobhan Oncology Pharmaceutical CO.
Full name of responsible person
Mitra Hajarian
Street address
No. 11, 5th Alley, Bucharest Ave, Argentina Sq, Tehran
City
Tehran
Province
Tehran
Postal code
7636318451
Phone
+98 21 8848 0161
Email
info@sobhanpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sobhan Oncology Pharmaceutical CO.
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Simin Baspar Teyf Gostar Company
Full name of responsible person
Dariush Omidar
Position
Lab. Manager
Latest degree
Master
Other areas of specialty/work
bioanalysis
Street address
No.48, Ferdos square
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Email
Dariush.omidfar@gmail.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
All information and data of the study will remain secured based on the agreement established between researcher and drug producer.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only protocol and methods of study are sharable
When the data will become available and for how long
The access to data will be possible after finishing of project (almost 6 months after receiving of IRCT Code).
To whom data/document is available
Pharmaceutical and medical sciences researchers
Under which criteria data/document could be used
Projects information's for any publications is not allowed.
From where data/document is obtainable
By email to the project manager (shokri.j@gmail.com)
What processes are involved for a request to access data/document
These information are confidential and be under disposal of the project's contractor. Upon request, the information will be accessed to the applicant by the Executor's email after receiving contractor's consent.