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Bioequivalence study of Empagliflozin Metformin 12.5-1000 mg (Tehran chemie Pharmaceutical Company) versus Synjiardy (Boehringer Ingelheim) Tablet after single oral dosing in healthy volunteers

Protocol summary

Study aim
Bioequivalence study of Empagliflozin 10 mg (Tehran Chemie Pharmaceutical Company) versus Jardiance(Boehringer Ingelheim) Tablet after single oral dosing in healthy volunteers
Design
Bioequivalence study, with control group, double-blind, randomized, on 24 volunteers, from each volunteer 20 blood samples will be taken. Sealed envelope is used for randomization.
Settings and conduct
The location of the study is Blood collection center of Tam Pouya Company located in Tehran. The study will be blinded to the study participants by taking out the drugs from the original packages and placing the test and reference drugs in the same packages, and the participants will not be aware of the type of drug they will take. The crossover design is such that the Iranian drug will be prescribed to the first group in the first week and to the second group in the second week. Brand medicine, on the contrary of the Iranian medicine will be prescribed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: general health (liver, heart and kidneys), body mass index (18-28), informed consent, age (50-18) Exclusion criteria: smoking, history of cardiovascular disease, history of liver disease and Renal, alcohol and drug addiction, history of allergy to Empagliflozin metformin
Intervention groups
Receives one tablet of test drug (Empagliflozin Metformin ۱۲.۵-۱۰۰۰ mg tablet pharmaceutical company Tehran Chemie). Control group: Receives one reference medicine tablet Synjiardy ۱۲.۵-۱۰۰۰ mg tablet Boehringer Ingelheim pharmaceuticals)
Main outcome variables
Drug concentration in plasma samples

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220111053692N17
Registration date: 2024-05-16, 1403/02/27
Registration timing: prospective

Last update: 2024-05-16, 1403/02/27
Update count: 0
Registration date
2024-05-16, 1403/02/27
Registrant information
Name
Bardia Jamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 4707
Email address
info@tampouya.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-05-27, 1403/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Empagliflozin Metformin 12.5-1000 mg (Tehran chemie Pharmaceutical Company) versus Synjiardy (Boehringer Ingelheim) Tablet after single oral dosing in healthy volunteers
Public title
Bioequivalence study of Empagliflozin Metformin 12.5-1000 mg
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Being male Being at the age of 18 to 55 years old. Weight in range of 10 % of proper body weight. All volunteers should be in a good health condition on the basis of medical history, physical examination, routine blood test. Possessing negative test for hepatitis B surface antigen (HBs-Ag), Antihepatitis-C antibody (anti-HCV) and anti-HIV.
Exclusion criteria:
Volunteers with hypersensitivity to Empagliflozin metformin Those with known history of drug abuse, alcohol consuming or cigarette smoking. Taking medications that have drug interactions with Empagliflozin metformin until one month before studying. Disinclination to take the test. Blood donation or blood loss of more than 200 ml in the past month.
Age
From 18 years old to 55 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly allocate people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are placed in random order. After entering the study, each candidate will take an envelope, numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 (test product) and group B will receive intervention 2 (reference product) and after the first period, the interventions of the two groups will be moved for the second period
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a Double-blind (participant) clinical trial. Empagliflozin metformin and Synjiardy tablets are removed from the package by the administrator and placed in similar and coded cans. Medicine and placebo are the same in terms of the method of administration
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committees of The Institute of Pharmaceutical Sciences,Tehran University of Medical Sciences
Street address
Research Institute of Pharmaceutical Sciences, second floor of the old building, Faculty of Pharmacy, 16 Azar Street, Enqelab Square
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-02-17, 1402/11/28
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.172

Health conditions studied

1

Description of health condition studied
Bioequivalence study of Empagliflozin Metformin 12.5-1000 mg (Tehran Chemie Pharmaceutical Company) versus Synjiardy(Boehringer Ingelheim) Tablet after single oral dosing in healthy volunteers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Drug concentration in plasma samples
Timepoint
In times 0, 0/5, 0/75, 1, 1/5, 2, 2/5, 3, 3/5, 4, 4/5, 5, 6, 8, 10, 24, 48 Hours after the start of the intervention
Method of measurement
Chromatography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receives one tablet of test drug (Empagliflozin Metformin ۱۲.۵-۱۰۰۰ mg tablet pharmaceutical company Tehran Chemie). Blood samples were taken from the volunteers for 48 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector.
Category
Other

2

Description
Control group: Receives one reference medicine tablet (Synjiardy ۱۲.۵-۱۰۰۰ mg tablet Boehringer Ingelheim pharmaceuticals). Blood samples were taken from the volunteers for 48 hours at the mentioned times after drug administration and the drug concentration in plasma samples was measured by liquid chromatography with UV detector
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Tam Pouya Consulting & Research Company
Full name of responsible person
Bardia Jamali
Street address
No. 7 ,Navard Ave ,17 Shahrivar St., 5th Km Fat`h Highway
City
Tehran
Province
Tehran
Postal code
1378756411
Phone
+98 21 6107 4387
Fax
+98 21 6107 4070
Email
info@tampouya.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran Chemie Pharmaceutical Company
Full name of responsible person
Dr. Ali Mehramizi
Street address
Navard Ave, 17 Shahrivar St.,5th Km Fat`h Highway
City
Tehran
Province
Tehran
Postal code
1378756411
Phone
+98 21 6680 0225
Fax
+98 21 6107 4132
Email
info@tehranchemie.com
Web page address
https://www.tehranchemie.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran Chemie 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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tam Pouya Consulting & Research Company
Full name of responsible person
Bardia Jamali
Position
manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 1,No. 1,Crot Building, Jahan mehr Street,Shahid Gomnam Street,Fatemi Square
City
Tehran
Province
Tehran
Postal code
1431653941
Phone
+98 21 8897 4707
Fax
+98 21 8897 4707
Email
info@tampouya.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tam Pouya Consulting & Research Company
Full name of responsible person
Bardia Jamali
Position
manager
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 1, No. 1, Crot Building, Jahan mehr Street, Shahid Gomnam Street, Fatemi Square
City
Tehran
Province
Tehran
Postal code
1431653941
Phone
+98 21 8897 4707
Fax
+98 21 8897 4707
Email
info@tampouya.com

Person responsible for updating data

Contact
Name of organization / entity
Tam Pouya Consulting & Research Company
Full name of responsible person
Motahareh Moafi
Position
Office worker
Latest degree
Bachelor
Other areas of specialty/work
Office worker
Street address
Unit 1, No. 1, Crot Building, Jahan mehr Street, Shahid Gomnam Street, Fatemi Square
City
Tehran
Province
Tehran
Postal code
1431653941
Phone
+98 21 8897 4707
Fax
+98 21 8897 4707
Email
info@tampouya.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
No more information
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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