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Bioequivalence study of empagliflozin 25 mg of Cosar Pharmaceutical Co. in comparison with the reference sample of Jardiance made by Boehringer company.

Protocol summary

Study aim
This study will be performed to compare the pharmacokinetics and invivo parameters of Empagliflozin 25 mg Tablet.
Design
Non-blinded, randomized, crossover in vivo bioequivalence study in 24 healthy males under fasting conditions. Block randomization for a treatment sequence of Test/Reference or Reference/Test is used.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Noor Research and Development Institute (Tarasht, Tehran). 2 dosing periods will be separated by a 7-day washout period.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthy subjects (male) should be between 20-45 years old. subjects how have body mass index (BMI) Within 15% of normal range between 18.5-30 (Kg/m2). Exclusion Criteria: Subjects with known allergy to the products tested. Subjects must not have a historical specific diseases or abnormal values in laboratory tests and general clinical examination.
Intervention groups
Intervention group 1: Empagliflozin 25 mg Tablet, produced by Cosar Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention group 2: Jardiance 25 mg Tablet, produced by Boehringer Ingelheim is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Main outcome variables
Peak Plasma Concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180620040164N63
Registration date: 2024-06-14, 1403/03/25
Registration timing: prospective

Last update: 2024-06-14, 1403/03/25
Update count: 0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Mahsa Javadi
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2024-09-25, 1403/07/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of empagliflozin 25 mg of Cosar Pharmaceutical Co. in comparison with the reference sample of Jardiance made by Boehringer company.
Public title
Comparative in vivo evaluation of 2 Empagliflozin 25 mg Combined Tablet formulations.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) should be between 20-45 years old. subjects how have body mass index (BMI) Within 15% of normal range between 18.5-30 (Kg/m2). Subjects with normal vital signs. Subjects who agree with patient consent form.
Exclusion criteria:
Subjects with known allergy to the products tested. Subjects must not have a historical specific diseases or abnormal values in labratory tests and general clinical examination. Chronic or acute diseases of the digestive system, such as diseases related to the esophagus, gastritis, peptic ulcer, intestinal inflammation, bleeding in the digestive tract, or digestive system surgery during the last three years. Having problems with vascular system, endocrine system, nervous system, digestive system, respiratory system, blood system, immune system, mental and metabolic system. Performing surgery within 4 weeks before drug administration or at the time of clinical study. Smoking more than 10 cigarettes per day, losing more than 500 ml of blood in less than 7 days. A history of difficulty with donating blood or donation of more than 500 ml blood within 7 days prior to the start of the study.
Age
From 20 years old to 45 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization schedule will be generated with https://www.sealedenvelope.com/simple-randomiser/v1/lists. A 2*2 block randomization list is created. We have 12 blocks and within each two volunteer numbers (allocated after screening) for all 24 volunteers. According to this list, a treatment sequence of Test/Reference or Reference/Test will be given to each volunteer.
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,School of Pharmacy,Nursing&Midwifery-Shahid Beheshti University of medical sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2024-05-27, 1403/03/07
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.041

Health conditions studied

1

Description of health condition studied
Diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Peak Plasma Concentration (Cmax)
Timepoint
15 blood samples will be withdrawn pre-dose and at 20, 40 minutes,1, 1.5, 2, 2.5, 3, 4, 6, 8, 11, 24, 48 and 72 hours after intervention.
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)

Secondary outcomes

1

Description
AUC (Area Under the Concentration-Time Curve)
Timepoint
15 blood samples will be withdrawn pre-dose and at 20, 40 minutes,1, 1.5, 2, 2.5, 3, 4, 6, 8, 11, 24, 48 and 72 hours after intervention.
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)

Intervention groups

1

Description
Intervention group1: Empagliflozin 25 mg Tablet , produced by Cosar Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 2 will be given to these subjects.
Category
Treatment - Drugs

2

Description
Intervention group2: Empagliflozin 25 mg Tablet (Jardiance®), produced by Boehringer Ingelheim is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 07-day wash-out period the intervention 1 will be given to these subjects.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor Research & Development Institute (Tavan)
Full name of responsible person
Behzad Montaha Sangari
Street address
Sharif Innovation Station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Cosar Pharmaceutical Co.
Full name of responsible person
Dr. Babak Mesbahi
Street address
Darougar street, 17km Old Way Karaj-Tehran.
City
Tehran
Province
Tehran
Postal code
1415519871
Phone
+98 21 4492 1074
Email
info@cosarpharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cosar 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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Noor Research & Development Institute
Full name of responsible person
Behzad Montaha Sangari
Position
CEO(Chef Executive Officer)
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Seyed Mohsen Foroutan
Position
Principal investigator
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
mforoutan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Behzad Montaha Sangari
Position
CEO(Chef executive officer)
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah Street, Hosseini Square, Teymoury Street, Tarasht.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
Behzad_first@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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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