Bioequivalence study of Dimethyl fumarate capsule 240 mg manufactured by Alborzzagros versus originator brand in healthy volunteers in the fasted condition
Bioequivalence Study of dimethyl fumarate 240 mg capsule (Tecra)manufactured by Alborzzagos company versus originator brand (Tecfidera) manufactured by Biogen
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 (10h). The interval between these two periods is one week. In the first round of the study, the candidates divide into two groups. the first group receives a test capsule and the second group receives a brand capsule. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin laboratory in Tabriz
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 dimethyl fumarate.
Intervention groups
Intervention group 1: Tecfidera 240 mg capsule as a reference
Intervention group 2: Tecra 240 mg capsule as a test
Main outcome variables
Maximum drug concentration; time to reach maximum drug concentration; half-life of drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047902N26
Registration date:2023-02-10, 1401/11/21
Registration timing:prospective
Last update:2023-02-10, 1401/11/21
Update count:0
Registration date
2023-02-10, 1401/11/21
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
2023-04-04, 1402/01/15
Expected recruitment end date
2023-07-21, 1402/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Dimethyl fumarate capsule 240 mg manufactured by Alborzzagros versus originator brand in healthy volunteers in the fasted condition
Public title
Bioequivalence study of dimethyl fumarate 240 mg capsule
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 dimethyl fumarate
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:
26
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, 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). Alborzzagros's dimethyl fumarate and Originator brand capsules 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
2023-02-06, 1401/11/17
Ethics committee reference number
IR.TBZMED.REC.1401.983
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
the concentration of the active metabolite in plasma
Timepoint
Pre-dose, 0.33, 0. 66, 1, 1.33, 1.66, 2, 2.5, 3, 4, 5, 7, and 10 h after drug administration
Method of measurement
Liquid Chromatography Mass-Mass
Secondary outcomes
1
Description
Time to reach maximum plasma concentration
Timepoint
After intervention
Method of measurement
The time to reach the maximum metabolite concentration in plasma is recorded
2
Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time
Intervention groups
1
Description
Intervention group: single dose, one oral capsule of Tecfidera 240 mg manufactured by Biogen, as a reference product
Category
Treatment - Drugs
2
Description
Intervention group: Single dose, one oral capsule of Tecra 240 mg manufactured by Alborzzagros company as a test product
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Radin laboratory
Full name of responsible person
Javad Shokri
Street address
No.22, first floor, Azadi alley, Moalem st., Abureihan St
City
Tabriz
Province
East Azarbaijan
Postal code
5154995671
Phone
+98 914 313 5843
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
Faculty of Pharmacy, Islamic Azad university of Damghan, Cheshme Ali bolivar, Saadi square
City
Damghan
Province
Semnan
Postal code
3671637856
Phone
+98 23 3522 5046
Fax
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
Faculty of Pharmacy, Islamic Azad university of Damghan, Cheshme Ali bolivar, Saadi square
City
Damghan
Province
Semnan
Postal code
3671637856
Phone
+98 23 3522 5046
Fax
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
Faculty of Pharmacy, Islamic Azad university of Damghan, Cheshme Ali bolivar, Saadi square
City
Damghan
Province
Semnan
Postal code
3671637856
Phone
+98 23 3522 5046
Fax
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 as secure between researchers and related industries.