1. Home
  2. Approved trials
  3. » فارسی

In- Vivo Bioequivalence study of Everolimus tablet 10 & 0.75 mg SOBHAN ONCOLOGY (Everolimus 10mg) with brand drug (AFINITOR® 10mg Novartis) in Iranian healthy volunteers

Protocol summary

Study aim
In- Vivo Bioequivalence study of Everolimus tablet 10 & 0.75 mg SOBHAN ONCOLOGY (Everolimus 10mg) with brand drug (AFINITOR® 10mg Novartis) in Iranian healthy volunteers
Design
In-vivo bioequivalence study of test ( Everolimus tablet 10 & 0.75 mg SOBHAN ONCOLOGY, IRAN) in compared with reference drug (AFINITOR® 10mg Novartis, Switzerland). The single blind, Cross-over, two period, two groups (Intervention and control) and randomized (paper lottery randomization method) study with one week wash-out period.
Settings and conduct
This study will carried out in Simin Baspar Tayf Gostar Company, Tabriz, Iran. The number of participant is 24 healthy Iranian volunteers. This study is single blind by taking the drugs out of their original packaging, the volunteers will not know the The types of receiving drugs (test or brand). This study is a cross over, two periods, two times (each times is 72 hours) with a one-week wash-out period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: participants are between 18-60 years old, Normal body mass index (BMI in the range of 18-28). Exclusion criteria: smoking, History of heart, kidney or liver disease, Pregnancy, Drug addiction
Intervention groups
Single dose Everolimus tablet 10 & 0.75 mg SOBHAN ONCOLOGY Pharmaceuticals. Control group: brand drugs (AFINITOR® 10mg Novartis, Switzerland)
Main outcome variables
Determination of blood drug concentration.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200105046010N44
Registration date: 2021-11-15, 1400/08/24
Registration timing: registered_while_recruiting

Last update: 2021-11-15, 1400/08/24
Update count: 0
Registration date
2021-11-15, 1400/08/24
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
2021-11-11, 1400/08/20
Expected recruitment end date
2022-08-11, 1401/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Everolimus tablet 10 & 0.75 mg SOBHAN ONCOLOGY (Everolimus 10mg) with brand drug (AFINITOR® 10mg Novartis) in Iranian healthy volunteers
Public title
In-vivo Bioequivalence Test of Everolimus tablet with brand drugs (AFINITOR® 10mg Novartis).
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 History of cardiovascular disease History of liver or kidney disease Pregnancy Alcohol & Drug addiction History of hypersensitivity
Age
From 18 years old to 60 years old
Gender
Male
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: 2
13 plasma samples in each period with distinct time intervals for each subject
Randomization (investigator's opinion)
Randomized
Randomization description
For this reason, A 24- person group will be selected and divided to two 12-person 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 drug (Everolimus tablets) are withdrawal from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about the types of receiving drugs (test or brand).
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, 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
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.468

Health conditions studied

1

Description of health condition studied
In this study, the disease is not examined. Subject bio equivalence test and reference tablets Everolimus studied.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination of blood drug concentration.
Timepoint
Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours After prescribing the tablet.
Method of measurement
High Performance Liquid Chromatography tandem mass spectroscopy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: they will receive one test drug (Everolimus 10 or 0.75 mg Tablets SOBHAN ONCOLOGY. Iran). Blood samples will be taken during 72 hours at the mentioned times after drug administration and the concentration of Everolimus in blood samples will be measured by liquid chromatography- Tandem mass spectroscopy method.
Category
Treatment - Other

2

Description
Control group: Control group: will receive one test drug (AFINITOR® 10 or 0.75 mg Novartis Switzerland). Blood samples will be taken from the volunteers during 72 hours at the mentioned times after drug administration and the concentration of Everolimus in blood samples will be measured by High performance liquid chromatography- Tandem mass spectroscopy method.
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 3693 4125
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
Full 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
Full 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
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 Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@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
These date are as secure between researcher and related industries
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
Only protocol and methods of study are shareable.
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
This information is confidential and is at the disposal of the project sponsor. Upon request, the information will be provided to the applicant by the contractor's email after the
Comments
Loading...