Bioequivalence study and evaluation of pharmacokinetic parameters of Dimethyl fumarate medicine manufactured by Zistdaru danesh company (Teczifuma 240) versus Tecfidera 240 manufactured by Biogen Company (originator brand) in healthy volunteers
Bioequivalence study of Dimethyl fumarate 240mg manufactured by Zistdaru danesh company (Teczifuma 240mg) versus originator brand (Tecfidera 240mg) manufactured by Biogen company
Design
bioequivalence study, crossover, a blind, 24 healthy volunteers, a simple mu randomized study
Settings and conduct
The study will be conducted in two-way, cross-over and fasting, and on two series of healthy volunteers. The study will be conducted in two 12-hour periods. The interval between these two periods, which is called the wash-out time, is determined by the half-life of the drug plasma, which according to scientific sources at this time should be at least 5 to 7 half-life of the drug. Given that the biological half-life of the drug is in drug form, the time to clear the drug will be two weeks. Blood samples are taken by the doctor immediately before and after the drug is taken by the volunteers, and the steps for preparing the samples include plasma separation and drug extraction to analyze the amount of drug on them.
Participants/Inclusion and exclusion criteria
Healthy volunteers 18-60 years old
Intervention groups
In this study, two groups of intervention and control are not applicable. Both groups will receive test-reference medicine and testing on two different occasions, and therefore the test results will be independent of individual differences and will only indicate differences in the formulation of the two drugs.
Main outcome variables
maximum drug concentration, time to reach to maximum drug concentration, half life of drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047902N1
Registration date:2020-06-26, 1399/04/06
Registration timing:prospective
Last update:2020-06-26, 1399/04/06
Update count:0
Registration date
2020-06-26, 1399/04/06
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
2020-06-30, 1399/04/10
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study and evaluation of pharmacokinetic parameters of Dimethyl fumarate medicine manufactured by Zistdaru danesh company (Teczifuma 240) versus Tecfidera 240 manufactured by Biogen Company (originator brand) in healthy volunteers
Public title
Bioequivalence study of Dimethyl fumarate capsule manufactured by Zistdaru danesh company (Teczifuma 240mg) in Iranian healthy volunteers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart and Kidney), Body Mass Index (18-28), Conscious Consciousness, Age (18-60)
Exclusion criteria:
Smoking, history of cardiovascular disease, history of liver and kidney disease, pregnancy, alcohol and drug addiction, history of drug allergy
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
More than 1 sample in each individual
Number of samples in each individual:
30
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People in different age groups are invited to collaborate through the advertisement. Then people are selected and individuals in each group randomly selected from the qualified people to participate in the project. The first twelve are considered as (first sequence: Teczifuma recipient) and the second twelve are considered as (second sequence:Tecfidera recipient).
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blind side clinical trial (volunteers). Tecfidera and Teczifuma 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
Ethics committee of Islamic Azad University-Damghan Branch
Street address
Zistdaru danesh Co., Second floor, No.98, Bozorgmehr St., Velsale Shirazi st., Enghelan St.
City
Tehran
Province
Tehran
Postal code
1417833714
Approval date
2019-04-24, 1398/02/04
Ethics committee reference number
IR.IAU.DAMGHAN.REC.1398.004
Health conditions studied
1
Description of health condition studied
In this study, the disease is not examined. The subject of the study is the bioequivalence study of the Dimethyl Fumarate capsule of test and reference in healthy volunteers.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination of concentration of active form of drug in bood
Timepoint
After taking blood sample
Method of measurement
HPLC-MASS MASS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: Volunteers take Teczifuma capsule drug, which is manufactured by Zistdaru danesh Company and contains 240 mg of dimethyl fumarate,as a test product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the active form of the drug in the blood is determined.
Category
Treatment - Drugs
2
Description
Intervention Group 2: Volunteers take Tecfidera capsule drug, which is manufactured by Biogen Company and contains 240 mg of dimethyl fumarate, as a reference product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the active form of the drug in the blood is determined.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zistdaru danesh Co.
Full name of responsible person
Sima Sadrai
Street address
School of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14155/6451
Phone
+98 21 6695 9054
Email
sadrai@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zistdaru danesh Co.
Full name of responsible person
Hooshmand Ilka
Street address
No. 10, 8th floor, Faraz building, Sahand St., Beheshti St.
City
Tehran
Province
Tehran
Postal code
1559836438
Phone
+98 21 4231 8100
Email
ilka@Zistdaru.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zistdaru danesh 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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Zistdaru danesh Co.
Full name of responsible person
Elham Ghasemian
Position
Deputy director of research and development
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zistdaru danesh Co., second floor, No.98, Bozorgmehr St., Vesale Shirazi St., Enghelab St
City
Tehran
Province
Tehran
Postal code
1417833714
Phone
+98 21 6696 5196
Email
ghasemian@zistdaru.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zistdaru danesh Co
Full name of responsible person
Elham Ghasemian
Position
Deputy director of research and development
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zistdaru danesh Co., second floor, No.98, Bozorgmehr St., Vesale Shirazi St., Enghelab St
City
Tehran
Province
Tehran
Postal code
1417833714
Phone
+98 21 6696 5196
Email
ghasemian@zistdaru.ir
Person responsible for updating data
Contact
Name of organization / entity
Zistdaru danesh Co
Full name of responsible person
Elham Ghasemian
Position
Deputy director of research and development
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zistdaru danesh Co., Second floor, No.98, Bozorgmehr St., Vesale Shirazi St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1417833714
Phone
+98 21 6696 5196
Email
ghasemian@zistdaru.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
blood concentration data
When the data will become available and for how long
8 months after publication of results
To whom data/document is available
University researchers
Under which criteria data/document could be used
Do similar studies
From where data/document is obtainable
Elham Ghasemian
Ghasemian@zistdaru.ir
What processes are involved for a request to access data/document
After evaluation of reasons to apply, it will be sent during 60 working days