In- Vivo Bioequivalence study of Sitagliptine/ Metformin tablet with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany) in Iranian healthy volunteers.
In- Vivo Bioequivalence study of Sitagliptine/ Metformin tablet 50/500mg Razak Co. with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany) in Iranian healthy volunteers.
Design
Single dose Sitagliptine/ Metformin tablet 50/500mg Razak Pharmaceutical Company.
Settings and conduct
This study will be conducted in two-way, cross-over and fasting, and on two sets of healthy volunteers. The study will be conducted in two periods of twenty-four 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
Participants/Inclusion and exclusion criteria
24 participants will be selected from non-smoking, non-pregnant people without history of heart, kidney and liver disease from both sex (male & female). The ages and BMIs of participant should be in the range of 18-55 and 18-28 respectively.
Intervention groups
Single dose Sitagliptine/ Metformin tablet 50/500mg Razak Pharmaceutical Company and Single dose Sitagliptine/ Metformin tablet JANUMET 50/500mg (Merck Sharp & Dohme, Gremany).
Main outcome variables
Determination of blood drug concentration.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N12
Registration date:2020-10-25, 1399/08/04
Registration timing:prospective
Last update:2020-10-25, 1399/08/04
Update count:0
Registration date
2020-10-25, 1399/08/04
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
2020-11-10, 1399/08/20
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Sitagliptine/ Metformin tablet with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany) in Iranian healthy volunteers.
Public title
Study of Sitagliptine/ Metformin table In-Vivo Bioequivalence in healthy volunteers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health (liver, heart, kidney)
Body Mass Index (BMI) between 18-28
Informed consent
Age between 18-60
Both male and female
Exclusion criteria:
Smoking
Hypersensitivity to the drug
Alcohol & Drug addiction
Pregnancy
Age
From 18 years old to 60 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
Random allocation law is the simplest method of finite randomization.This method represents a large block for the entire sample size,This means that a balance in the number of people assigned to each group will be achieved at the end of the study.For this purpose, first determine a total sample size (24 people), then write the names of the people on paper, and after folding in aluminum foil, pour it into a glass, and then randomly remove the papers and open the first 12 people in group A and The rest are selected as group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
It is necessary to apply the scientific method of blind testing in some fields, such as drug testing. Candidates are not aware of the test drug or brand name. 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. Sitagliptine/ Metformin and JANUMET are removed from their packaging by the executor and placed in similar and coded cans.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
No.48,Ferdows street, Ferdowsi Sq.
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Approval date
2020-08-24, 1399/06/03
Ethics committee reference number
IR.TBZMED.REC.1399.579
Health conditions studied
1
Description of health condition studied
In this study the bioequivalence of test and brand of Linagliptin tablets 5mg will evaluated.
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.
Method of measurement
Liquid Chromatography with tandem mass spectroscopy detector
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single dose of Sitagliptine/ Metformin tablet 50/500mg Razak Company as a test product.
Category
Treatment - Drugs
2
Description
Control group:Single dose of Sitagliptine/ Metformin tablet with brand drugs (JANUMET 50/500mg (Merck Sharp & Dohme, Gremany)
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
Razak Pharma
Full name of responsible person
Roya Aria
Street address
Km 10,Lashgari Expy, Tehran-IRAN
City
Tehran
Province
Tehran
Postal code
1389736615
Phone
+98 21 4452 5413
Fax
+98 21 4452 5410
Email
info@razakpharma.com
Web page address
http://razak-labs.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razak Pharma
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, 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 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
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
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.
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
After finishing of the protocol (Probably 6 months receiving 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
Contact with E-mail of the main researcher.
What processes are involved for a request to access data/document
Personal and academic details and the aim of the request.