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In- Vivo Bioequivalence study of Mesalazine SR granules 2 g, Teb Mofid Nikan Pharmed Co. (MODACOLIT® 2 g SR Granules) with brand drugs (PENTASA® 2g SR. granules) Ferring Pharmaceuticals Co, Germany in Iranian healthy volunteers.

Protocol summary

Study aim
In- Vivo Bioequivalence study of Mesalazine SR granules 2 g, Teb Mofid Nikan Pharmed Co. (MODACOLIT® 2 g SR Granules) with brand drugs (PENTASA® 2g SR. granules, Ferring Pharmaceuticals Co, Germany) in Iranian healthy volunteers.
Design
In-vivo bioequivalence study of Mesalazine SR granules 2 g Teb Mofid Nikan Pharma. in compared with reference drug (Ferring Pharmaceuticals Co, Gremany). The single blind, Cross-over, two period, two sequences (Intervention and control) and randomized study with one week wash-out period.
Settings and conduct
This study is carried out in Simin Baspar Tayf-Gostar Company, Tabriz, Iran. The study population is 24 healthy Iranian volunteers.This study is a single blind study and by taking out the drugs from the existing packaging, the volunteers will not know the time of receiving the test drug and the brand. This study is a cross over study that is performed in two time periods of 72 hours with a two-week wash-out period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-55 years, body mass index (BMI) in the range of 18-28. Exclusion criteria: History of heart, kidney and liver disease, Pregnancy, Drug addiction, Smoking
Intervention groups
Single dose Mesalazine SR granules 2 g Teb Mofid Nikan Pharma. Control group: brand drugs (Ferring Pharmaceuticals Co, Gremany)
Main outcome variables
Plasma drug concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200105046010N50
Registration date: 2021-12-25, 1400/10/04
Registration timing: registered_while_recruiting

Last update: 2021-12-25, 1400/10/04
Update count: 0
Registration date
2021-12-25, 1400/10/04
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
2021-12-12, 1400/09/21
Expected recruitment end date
2022-06-11, 1401/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Mesalazine SR granules 2 g, Teb Mofid Nikan Pharmed Co. (MODACOLIT® 2 g SR Granules) with brand drugs (PENTASA® 2g SR. granules) Ferring Pharmaceuticals Co, Germany in Iranian healthy volunteers.
Public title
In-vivo Bioequivalence Test of MODACOLIT SR Granules with brand drug (Ferring Pharmaceuticals Co, Gremany)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health Body mass index between18-28 Informed consent Being at the age of 18-55 years old
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 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, A 24- persons group will be selected and divided to two 12-persons groups randomly. The names of all volunteers will be written on paper pieces and wrapped in aluminum foils. The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Candidates are not aware of receiving the test drug or brand one. In a one-blind study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Test and Brand drugs 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 drug.
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
Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-11-15, 1400/08/24
Ethics committee reference number
IR.TBZMED.REC.1400.737

Health conditions studied

1

Description of health condition studied
Bio equivalence test
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plasma drug concentration
Timepoint
Sampling times in this study will be 0, 1, 2, 3, 4, 6, 7, 8, 9, 10, 10:30, 11, 12, 24, 36, 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: One test tablet (Mesalazine SR granules 2 g ، produced by Teb Mofid Nikan Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector
Category
Treatment - Other

2

Description
Control group: One Reference granule (PENTASA® 2g SR. granules, Ferring Pharmaceuticals Co, Gremany) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of Mesalazine in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. After one week wash out period, the test drug taken by other sequence of volunteers.
Category
Treatment - Other

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 square
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
Teb Mofid Nikan Pharmaceutical Co.
Full name of responsible person
Mohammad Reza Zargarzadeh
Street address
Tehran Shahid Beheshti Street Ahmad Qusayr Street, Pazhouheshgah(2) alley, fifth floor
City
Tehran
Province
Tehran
Postal code
3361658369
Phone
+98 21 8817 5119
Fax
+98 26 4422 8116
Email
info@mofidpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Teb Mofid Nikan Pharmaceutical 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
Persons

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, Daneshgah
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, University of Medical Sciences, Daneshgah Street,Tabriz East Azerbayjan
City
Tabriz
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
Simin Baspar Teyf Gostar Company
Full name of responsible person
Dariush Omidar
Position
Lab. Manager
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
No.48, Ferdos square
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Email
Dariush.omidfar@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
All information and data of the study will remain secured based on the agreement established between researcher and drug producer.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only protocol and methods of study are sharable
When the data will become available and for how long
The access to data will be possible after finishing of project (almost 6 months after receiving of IRCT Code).
To whom data/document is available
Pharmaceutical and medical sciences researchers
Under which criteria data/document could be used
Projects information's for any publications is not allowed.
From where data/document is obtainable
By email to the project manager (shokri.j@gmail.com)
What processes are involved for a request to access data/document
These information are confidential and be under disposal of the project's contractor. Upon request, the information will be accessed to the applicant by the Executor's email after receiving contractor's consent.
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