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In-vivo Bioequivalence Study of Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co Tablets of The Test Drug in Compared with The Reference Drug (GLYXAMBI® Tab 25/5 mg. Beohringer Ingelheim Germany) In Healthy Volunteers

Protocol summary

Study aim
In-vivo Bioequivalence Study of Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co Tablets of The Test Drug in Compared with The Reference Drug (GLYXAMBI® Tab 25/5 mg. Beohringer Ingelheim Germany) 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 (72h). The interval between these two periods is two 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. 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 or Linagliptin
Intervention groups
Intervention group 1:The Reference Drug (GLYXAMBI® Tab 25/5 mg. Beohringer Ingelheim Germany) Intervention group 2: Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co Tablets of The Test Drug
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200105046010N97
Registration date: 2024-02-21, 1402/12/02
Registration timing: prospective

Last update: 2024-02-21, 1402/12/02
Update count: 0
Registration date
2024-02-21, 1402/12/02
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
2024-04-20, 1403/02/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In-vivo Bioequivalence Study of Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co Tablets of The Test Drug in Compared with The Reference Drug (GLYXAMBI® Tab 25/5 mg. Beohringer Ingelheim Germany) In Healthy Volunteers
Public title
Bioequivalence Study of Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co
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 Alcohol and drug addiction History of allergy to Empagliflozin or linagliptin
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
More than 1 sample in each individual
Number of samples in each individual: 2
Randomization (investigator's opinion)
Randomized
Randomization description
En Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball, poured into a container, and mixed. The balls are then removed randomly from the container and divided in 2 groups of 12 test (A) and reference (B) drug recipients, then in the second phase, groups A and B will be cross-referenced to the test and drug recipients.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Test and Originator brand's tablets 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
No. 48, Ferdows street, Ferdowsi Sq.
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.TBZMED.REC.1402.788

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، 0،3، 3.5، 4.0، 6.0، 8.0، 10، 12، 24، 48 , 72h 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 tablet GLYXAMBI® 25/5 mg manufactured by Boehringer as a reference product. after washout period, the volunteers receive Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co
Category
Treatment - Drugs

2

Description
Intervention group: Single dose, one oral Empagliflozin/Linagliptin 25/5 mg Kharazmi Pharma Co as test product. after washout period, the volunteers receive GLYXAMBI® Tab 25/5 mg Boehringer Ingelheim Germany
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
Kharazmi Pharmaceutical Co
Full name of responsible person
Peiman Tarhami
Street address
No 115 ,kharazmi pharmaceutical DE ,Jalal ST ,Shahrak aesteqlal ,Tehran
City
Tehran
Province
Tehran
Postal code
1389716512
Phone
+98 21 4454 5413
Email
info@kharazmipharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi 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
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
No 4, 10th Ave. Boostan Street, Roshdieh, Tabriz
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
Others
Street address
Tabriz University faculty of Pharmacy
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
Others
Street address
Tabriz University Faculty of Pharmacy
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
En 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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