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Bioequivalence study of Empagliflozin/Metformin12.5/1000 mg ( EMZIP® 12.5/1000 mg) manufactured by Faran pharmed versus originator brand SYNJARDY® 12.5/1000 mg manufactured by ‌‌Boehringer ‌‌‌‌‌ Co in fasting condition in healthy volunteers

Protocol summary

Study aim
Bioequivalence study of Empagliflozin/Metformin12.5/1000 mg ( EMZIP® 12.5/1000 mg) manufactured by Faran pharmed versus originator brand SYNJARDY® 12.5/1000 mg manufactured by ‌‌Boehringer in fasting condition in healthy volunteers.
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct
The study is a single-blinded (Volunteers), cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (48h). The interval between these two periods is a week. In the first round of the study, the candidates were divided into two groups the first group received a test tablet and the second group received a brand tablet. In the second round, the first group received a brand tablet and the second group received a test tablet. The blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. Sampling is performed in Radin laboratory in Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcohol and drug addiction, History of allergy to Empagliflozin/Metformin
Intervention groups
Intervention group 1: Empagliflozin/Metformin12.5/1000 mg (SYNJARDY® 12.5/1000 mg) manufactured by ‌‌Boehringer as a reference Intervention group 2: Empagliflozin/Metformin12.5/1000 mg ( EMZIP® 12.5/1000 mg) manufactured by Faran pharmed Co. as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200105046010N93
Registration date: 2024-02-11, 1402/11/22
Registration timing: prospective

Last update: 2024-02-11, 1402/11/22
Update count: 0
Registration date
2024-02-11, 1402/11/22
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
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Empagliflozin/Metformin12.5/1000 mg ( EMZIP® 12.5/1000 mg) manufactured by Faran pharmed versus originator brand SYNJARDY® 12.5/1000 mg manufactured by ‌‌Boehringer ‌‌‌‌‌ Co in fasting condition in healthy volunteers
Public title
Bioequivalence study of Empagliflozin/Metformin12.5/1000 mg
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney) Body Mass Index (18-28) Informed consent Age (18-55 years old)
Exclusion criteria:
Smoking History of cardiovascular disease History of liver and kidney disease Alcoholism and Narcoticism History of allergy to Empagliflozin/Metformin
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
More than 1 sample in each individual
Number of samples in each individual: 2
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. People are randomly placed in one of the two study groups with the help of a random number table and receive the intervention related to the same group. The volunteers don't have any information about taking the test drug or brand drug
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Test and Originator brand's medicine 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 dosage form.
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 committe
Street address
Research and technology deputy,3rd floor, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.TBZMED.REC.1402.792

Health conditions studied

1

Description of health condition studied
This study is performed on healthy volunteers and drug concentration in plasma is determined.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Drug plasma concentration
Timepoint
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 48h after drug administration.
Method of measurement
Liquid Chromatography Mass-Mass

Secondary outcomes

1

Description
Time to reach maximum plasma concentration
Timepoint
After intervention
Method of measurement
Time to reach the maximum drug concentration in plasma is recorded.

2

Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time

Intervention groups

1

Description
Intervention group: single dose, one oral Empagliflozin/ Metformin 12.5/1000 mg (SYNJARDY® 12.5/1000 mg) manufactured by ‌‌Boehringer ‌‌‌‌‌ Co as a reference product. after the washout period, the volunteers receive Empagliflozin/Metformin12.5/1000 mg ( EMZIP® 12.5/1000 mg) manufactured by Faran pharmed.
Category
Treatment - Drugs

2

Description
Intervention group: Single dose, Empagliflozin/Metformin12.5/1000 mg ( EMZIP® 12.5/1000 mg) manufactured by Faran pharmed as a test product. after the washout, the volunteers receive Empagliflozin/Metformin12.5/1000 mg (SYNJARDY® 12.5/1000 mg) manufactured by ‌‌Boehringer ‌‌‌‌‌ Co
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Radin laboratory
Full name of responsible person
Javad Shokri
Street address
No.22, first floor, Moalem st., Abureihan St
City
Tabriz
Province
East Azarbaijan
Postal code
5154995671
Phone
+98 914 313 5843
Email
Shokri.j@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Faran Pharmed company
Full name of responsible person
Parsa Sirat
Street address
unit 1, No.32, Nirue entezami st., Attar square, Vanak Square
City
Tehran
Province
Tehran
Postal code
1994767611
Phone
+98 21 5794 1000
Email
info@faranpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faran Pharmed 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
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, 10th Ave. Boostan Street, Roshdieh
City
Tabriz
Province
East Azarbaijan
Postal code
5155935357
Phone
+98 41 3661 4125
Fax
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
No 4, 10th Ave, Boostan Street, Roshdieh
City
Tabriz
Province
East Azarbaijan
Postal code
5155935357
Phone
+98 41 3661 4125
Fax
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
No 4, 10th Ave. Boostan Street, Roshdieh
City
Tabriz
Province
East Azarbaijan
Postal code
5155935357
Phone
+98 41 3661 4125
Fax
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 data are as secure between researchers 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
No - There is not a plan to make this available
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