Randomized, single-dose, crossover comparative bioequivalence study of Teriflunomide (Trigio®) 14 mg tablets produced by Zahravi Pharmaceutical Co. versus Aubagio® tablets of Sanofi Genzyme Co. in 14 healthy male under fasting conditions
To demonstrate bioequivalence of single dose test formulation of Zahravi pharmaceutical Co Terifunomide 14 mg tablet versus Aubagio® (Sanofi Genzime Company) as reference.
Design
Single dose, crossover bioequivalence study of Terifunomide 14 mg tablets of Zahravi pharmaceutical Co. (®Trigio) versus Aubagio® (Sanofi Genzime Company) in 14 healthy male under fasting condition.
Settings and conduct
Study place: Drug Applied Research Center affiliated to Tabriz University of Medical Science. Place for blood and plasma sample analysis: Imam Reza Medical Research and Trainning Hospital. 14 healthy male volunteers received each of two test or reference Terifunomide 14 mg tablets in random sequence according to the randomization schedule. Receiving drug periods were 21 day apart from each other and after the washout period, subjects received the other product. Blood samples were taken from all participants before receiving the drug and 72 hours after that at determined time points for pharmacokinetic evaluations (0, 0.25, 0.5 ، 1, 1.5، 2, 3، 4 ، 5, 6، 8، 12، 24، 48 and 72 hours).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy male subjects in the age range of 18-60 years and BMI (Body Mass Index) of 18.5-30. Exclusion criteria: subjects with a history of disease and unusual measures in blood and clinical examination and heavy smokers.
Intervention groups
Intervention group 1 (Test): Terifunomide 14 mg tablet, produced by Zahravi pharmaceutical Co. is the test product. In each period, 7 of 14 subjects will be given single oral dose of this product. Control group 2 (Reference): Aubagio® 14 mg tablets (produced by Sanofi Genzime co.) is the reference product. In each period, 7 of 14 subjects will be given single oral dose of this product.
Main outcome variables
Peak Plasma Concentration (Cmax); Area under the concentration-time curve (AUC).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200407046981N1
Registration date:2020-04-18, 1399/01/30
Registration timing:prospective
Last update:2020-04-18, 1399/01/30
Update count:0
Registration date
2020-04-18, 1399/01/30
Registrant information
Name
Fatima Molavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 2700
Email address
molavif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, single-dose, crossover comparative bioequivalence study of Teriflunomide (Trigio®) 14 mg tablets produced by Zahravi Pharmaceutical Co. versus Aubagio® tablets of Sanofi Genzyme Co. in 14 healthy male under fasting conditions
Public title
Bioequivalence study of Teriflunomide 14 mg tablets produced by Zahravi Pharmaceutical Co. versus Aubagio® tablets of Sanofi Genzyme Co. in 14 healthy male under fasting conditions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects with BMI 18.5-30 kg/m2
Not having any abnormal finding in laboratory examination or during physical examination.
Not having a history of any significant disease.
Subjects who agree with patient consent form.
Exclusion criteria:
Known hypersensitivity or idiosyncratic reaction to Ondansetron or any ingredients.
Subjects with BP ≤ 9060 mm/Hg or BP ≥ 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma (during past 5 years), DM, psychosis or glaucoma.
Regular smoker who smokes more than ten cigarettes daily.
Taking any medicine during two week before dosing
Age
From 16 years old to 60 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Each subject is identified by a number from 1 to 14. This number is allocated according to their entrance to volunteers' list in the screening day. Then, the following randomization table is used according to the crossover design of the study. All participants randomized into two sequences of Test/Reference and Reference/Test products Subjects Dosing Sequence Day 1 Day 22. 1 R/T Reference Test 2 R/T Reference Test 3 R/T Reference Test 4 R/T Reference Test 5 R/T Reference Test 6 R/T Reference Test 7 R/T Reference Test 8 T/R Test Reference 9 T/R Test Reference 10 T/R Test Reference 11 T/R Test Reference 12 T/R Test Reference 13 T/R Test Reference 14 T/R Test Reference.
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
Iran National Committee for Ethics in Biomedical Research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
01419943471
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.TBZMED.REC.1398.1316
Health conditions studied
1
Description of health condition studied
Immunomodulatory drug for the treatment of Multiple Sclerosis (MS)
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS
Intervention groups
1
Description
Intervention group (Test): Teriflunomide 14 mg tablets, produced by Zahravi pharmaceutical Co. is the test product. In each period, 7 of 14 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
2
Description
Intervention group (Reference): Teriflunomide 14 mg tablets (Aubagio®), produced by Sanofi Genzime Company is the reference product. In each period, 7 of 14 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Drug Applied Research Center
Full name of responsible person
Hamed Hamishehkar
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Fax
+98 41 3336 7914
Email
Hamishehkar.hamed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahravi pharmaceutical company
Full name of responsible person
Hussein Eslami
Street address
No. 23, Entrance No. 2, Darupakhsh Factories, Daropakhsh St., Karaj (Lashgari) Special Road, 18th Corner, Tehran
City
Tehran
Province
Tehran
Postal code
1397116396
Phone
+98 21 4499 1893
Fax
+98 21 4499 4315
Email
CEO@zahravipharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahravi pharmaceutical 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
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Email
Hamishehkar.hamed@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jaber Emami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7111
Fax
+98 31 3668 0011
Email
Emami@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatima Molavi
Position
PhD Student of pharmaceutics
Latest degree
Medical doctor
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Email
F.molavi85@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