In- Vivo Bioequivalence study of Favipiravir tablet 200mg ABIDI with brand drugs (AVIGAN 200mg, Tayoma Chemical Co. Ind. Japan) in Iranian healthy volunteers.
In- Vivo Bioequivalence study of Favipiravir tablet 200mg ABIDI with brand drugs (AVIGAN 200mg, Tayoma Chemical Co. Ind. Japan) in Iranian healthy volunteers.
Design
Single dose, randomized, two sequences, two period crossover with a washout period.
Settings and conduct
This study will be conducted as cross-over and fasting, and on two sets of healthy volunteers. The study will be conducted in two periods of 72 hours.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 should be at least 5 to 7 half-life of the drug in the case of the drug under study. The plan will take a week to clean up the drug, given the biological half-life of the drugs in the drug form.In the first round, candidates are divided into two groups, and the first group receives a test tablet and the second group receives a similar tablet. Blood samples will taken by the volunteer by the technician immediately after taking the drug, and the preparation steps of the samples, including plasma separation and drug extraction, are performed to analyze the amount of drug on them.
Participants/Inclusion and exclusion criteria
24 healthy volunteers will be considered. The ages and BMIs of participant should be in the range of 18-60 and 18-28 respectively.
Intervention groups
Intervention group Single dose Favipiravir 200mg ABIDI Pharmaceutical Company with brand drugs (AVIGAN 200mg, Tayoma Chemical Co. Ind. Japan)
Main outcome variables
Determination of blood drug concentration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N30
Registration date:2021-04-26, 1400/02/06
Registration timing:registered_while_recruiting
Last update:2021-04-26, 1400/02/06
Update count:0
Registration date
2021-04-26, 1400/02/06
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
2021-03-05, 1399/12/15
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Favipiravir tablet 200mg ABIDI with brand drugs (AVIGAN 200mg, Tayoma Chemical Co. Ind. Japan) in Iranian healthy volunteers.
Public title
In-vivo Bioequivalence Test of Favipiravir® tablet with brand drugs (AVIGAN® 200mgTAYOMA Chemical Ind. Co).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health
Body mass index(18-28)
Informed consent
Age(18-60)
Exclusion criteria:
Smoking
A history of cardiovascular disease
A history of liver & kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Age
From 18 years old to 60 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
Random allocation law will be used for randomization of volunteers in this study. This method represents a large block for the total sample size, which means that a balance in the number of people assigned to each group will be obtained at the end of the study. By this method, sequences 1(subjects no: 1-12) and sequences 2 (subjects no: 13-12) will be selected by using a simple paper lottery. the first and second 12 persons will be considered as sequence 1 (Group A) and sequence 2 (Group B) respectively.
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, Tabriz University of Medical Sciences
Street address
Third floor of TUMS (Tabriz University of Medical Sciences) central building, Dneshgah St. Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.TBZMED.REC.1399.668
Health conditions studied
1
Description of health condition 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 with tandem mass spectroscopy detector
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group received one test drug table(Favipiravir tablet 200mg ABIDI Pharmaceutical Company). Blood samples were taken two period (72 hrs) with one week wash out time. The concentration of Favipiravir in blood samples was measured by liquid chromatography tandem mass spectroscopy method. Due to the cross-over of the plan, the candidates are placed in the intervention and control group in turn.
Category
Treatment - Drugs
2
Description
Control group: Control group received one test drug table (AVIGAN 200mg, Tayoma Chemical Co. Ind. Japan ). Blood samples were taken from the volunteers for 72 hours at the mentioned times after drug administration and the concentration of Favipiravirin blood samples was measured by liquid chromatography with mass spectroscopy detector. Due to the crosover of the plan, the candidates are placed in the intervention and control group in turn.
Category
Treatment - Drugs
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 Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Email
Shokri.j@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
ABIDI Pharmaceutical Company
Full name of responsible person
Amir Razavian
Street address
8 km of Shahid Lashkari highway, Karaj special road. Obaidi Boulevard No. 72
City
Tehran
Province
Tehran
Postal code
1389776363
Phone
+98 21 4452 2451
Email
info@abidi-diabetes.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
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
Other
Person responsible for general inquiries
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.
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
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences.
City
Tabeiz
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.
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