In vivo fasted-state bioequivalence study of Terflunomide 14 mg tablet
Design
The clinical trial has control and test groups with crossover, randomized design, without blinding on twenty-four healthy volunteers. To randomly assign participants in two groups, the lottery method will be used.
Settings and conduct
After oral administration of 14 mg tablet to qualified volunteer, the blood samples will be collected up to 72 hours. Each volunteer will receive a single dose of drug in two periods. The concentration of drug in blood samples will be measured by liquid chromatography equipped with mass spectroscopy detector. The study will be performed in Faculty of Pharmacy, Tabriz University of Medical Sciences. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: General Health in terms of Liver, Heart and Kidney, Age of 18-55 years old. Exclusion criteria: Smoking, Pregnancy, Alcohol and drug addiction, History of drug allergy.
Intervention groups
Intervention group will receive a single oral dose of test drug product (Teriflunomide 14 mg tablet manufactured by Sobhan Oncology, Iran) and Control group will receive a single dose of reference drug product (Teriflunomide 14 mg tablet manufactured By sanofi Co.). Washout period will be Four weeks. Considering the cross-over nature of the study, in the second week, intervention group will receive the Teriflunomide reference tablet and Control group will receive Teriflunomide tablet of Sobhan Oncology Co. then the blood sampling process will be repeated.
Main outcome variables
Plasma drug concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220211053992N66
Registration date:2026-04-27, 1405/02/07
Registration timing:prospective
Last update:2026-04-27, 1405/02/07
Update count:0
Registration date
2026-04-27, 1405/02/07
Registrant information
Name
Hadi Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 8801
Email address
valizadehh@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-21, 1405/02/31
Expected recruitment end date
2027-01-20, 1405/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In vivo fasted-state bioequivalence study of Teriflunomide Tablets manufactured by Sobhan oncology Pharmaceutical Co. compared to innovator product
Public title
Bioequivalence study of Teriflunomide tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (in terms of Liver, Heart and Kidney)
Age (18-55 years)
Exclusion criteria:
Smoking
History of drug allergy
Pregnancy
Alcohol and drug addiction
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign participants in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope. Numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of both groups will change for the second period.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
No.2 Central Building 3rd Floor, Tabriz University of Medical Sciences, Daneshgah st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Approval date
2026-04-13, 1405/01/24
Ethics committee reference number
IR.TBZMED.REC.1405.037
Health conditions studied
1
Description of health condition studied
In the present study, the products will be administered to healthy volunteers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma concentration of drug
Timepoint
Before drug administration and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48 and 72 hours after drug administration
Method of measurement
HPLC (High performance liquid chromatography)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will receive a single oral dose of test product (Teriflunomide 14 mg tablet manufactured by Sobhan Oncology, Iran) in fasted state. Samples will be collected for 72 hours. Washout period will be Four weeks. In the second week this group will receive Teriflunomide 14 mg tablet manufactured in canada and the blood sampling process will be repeated.
Category
Treatment - Drugs
2
Description
Control group: Control group will receive a single oral dose of reference product (Teriflunomide 14 mg tablet manufactured in Canada) in fasted state. Samples will be collected for 72 hours. Washout period will be Four weeks. In the second week this group will receive Teriflunomide 14 mg tablet manufactured by Sobhan Oncology Co. and the blood sampling process will be repeated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Pharmacy, Tabriz University of Medical Sciences
Full name of responsible person
Hadi Valizadeh
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaboori st., Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
+98 41 3334 4798
Email
valizadehh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sobhan Oncology Co.
Full name of responsible person
Hamed Mohammadpour
Street address
Third Street, Sanat Boulevard 2, Industrial City
City
Rasht
Province
Guilan
Postal code
4337188657
Phone
+98 13 8822 4131
Email
info@sobhanoncology.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sobhan Oncology Co.
Proportion provided by this source
100
Public or private sector
Public
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
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Valizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaboori st., Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
Email
valizadehh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Valizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaboori st., Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
Email
valizadehh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Valizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaboori st., Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
Email
valizadehh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available