1. Home
  2. Approved trials
  3. » فارسی

In- Vivo Bioequivalence study of Empagliflozin-Metformin tablet (EMPATUS Plus® 25/1000 mg ,Pars Darou Pharma, Iran) with brand drug (Synjardy® 25/1000 mg, Boehringer Ingelheim, Germany) in Iranian healthy

Protocol summary

Study aim
In- Vivo Bioequivalence study of Empagliflozin-Metformin tablet (EMPATUS Plus® 25/1000 mg ,Pars Darou Pharma, Iran) with brand drug (Synjardy® 25/1000 mg, Boehringer Ingelheim, Germany) in Iranian healthy
Design
In-vivo bioequivalence study of EMPATUS Plus tablet Pars Darou Pharma. in compared with reference drug (Synjardy, Boehringer Ingelheim, German). The study design is single blind, Cross-over, two period & two groups (Intervention and control) with one week wash-out time. Randomization of the drug types in each period will perform by paper lottery randomization.
Settings and conduct
Study background is biopharmacy and pharmcokinetics. Place of study is Simin Baspar Tayf-Gostar Inc, Tabriz. Study blinding will done by taking the test and reference drugs out of their original packaging and put them in the similar packaging. The volunteers will not be informed about the type of received drug. In cross-over design, the test drug will taken by group 1 in first period and by group 2 in second period. The reference drug also will taken by group 2 in the first period and by group 1 in the second 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 EMPATUS Plus tablet Pars Darou Pharma. Control group: brand drugs (Synjardy, Boehringer Ingelheim, German)
Main outcome variables
Plasma drug concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200105046010N60
Registration date: 2022-05-05, 1401/02/15
Registration timing: registered_while_recruiting

Last update: 2022-05-05, 1401/02/15
Update count: 0
Registration date
2022-05-05, 1401/02/15
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
2022-03-09, 1400/12/18
Expected recruitment end date
2022-09-09, 1401/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Empagliflozin-Metformin tablet (EMPATUS Plus® 25/1000 mg ,Pars Darou Pharma, Iran) with brand drug (Synjardy® 25/1000 mg, Boehringer Ingelheim, Germany) in Iranian healthy
Public title
In-vivo Bioequivalence Test of Empagliflozin-Metformin tablets with brand drug (Synjardy® 25/1000 mg, Boehringer Ingelheim, Germany)
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
No information
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)
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
Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.TBZMED.REC.1400.825

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, 0:30, 1, 1:30, 2, 2:30, 3, 4, 6, 8, 10, 12, 24, 48 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 (EMPATUS Plus® 25/1000 mg ,Pars Darou Pharma, Iran) 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 tablet (Synjardy® 25/1000 mg, Boehringer Ingelheim, German) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of drag in plasma samples will be measured by liquid chromatography with mass spectroscopy detector.
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
Pars Darou Pharmaceutical Company
Full name of responsible person
Amir Garmabadri
Street address
Tehran, the first square of Tehranpars, in front of 144 East Street, No.13
City
Tehran
Province
Tehran
Postal code
1654713691
Phone
+98 21 7770 4061
Email
info@parsdarou.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pars Darou 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
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, 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 updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dariush.omidfar
Position
Lab. Manager
Latest degree
Master
Other areas of specialty/work
Others
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.
Comments
Loading...