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Comparative bioequivalence study of the Empagliflozin 25-mg Tablets manufactured by Rayhaneh Pharmaceutical Company

Protocol summary

Study aim
Demonstration of bioequivalence of Empagliflozin tablet 25 mg of Rayhaneh Co. with Jardiance® tablet manufactured by Boehringer Ingelheim after single dose administration.
Design
Single dose, randomized and crossover bioequivalence study of Empagliflozin tablet 25 mg by Rayhaneh Co. with Jardiance® (Boehringer Ingelheim) in 24 healthy volunteers in two groups.
Settings and conduct
Study place and the place for blood sample analysis are the Drug Applied Research Center affiliated to Tabriz University of Medical Science, respectively. 24 healthy volunteers will receive one of the 25 mg empagliflozin tablets test or reference in random sequence according to the randomization schedule. The interval between receiving the medicine (washout period) is 7 days, If the first sequence receives Iranian medicine, they will receive brand medicine. Blood samples will be taken from all participants before and after receiving the drug at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours after dosing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy subjects in the age range of 18-60 years and BMI (Body Mass Index) of 18-30. Exclusion criteria: Subjects with Blood Pressure ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma and regular smoker.
Intervention groups
ntervention group 1: Empagliflozin tablet 25 mg by Rayhaneh Co. is the test product. Intervention group 2: Jardiance® (Boehringer Ingelheim) is the reference product. In each period, 12 of 24 subjects will be given single dose of this product. After the washout period, the volunteers are placed in the opposite group.
Main outcome variables
Peak Plasma Concentration (Cmax); Area under the concentration-time curve (AUC).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130313012810N17
Registration date: 2023-11-08, 1402/08/17
Registration timing: prospective

Last update: 2023-11-08, 1402/08/17
Update count: 0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Hamed Hamishehkar
Name of organization / entity
Drug Applied Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3311
Email address
hamishehkar.hamed@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-16, 1402/08/25
Expected recruitment end date
2023-11-28, 1402/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of the Empagliflozin 25-mg Tablets manufactured by Rayhaneh Pharmaceutical Company
Public title
Comparative bioequivalence study of the Empagliflozin 25-mg Tablets manufactured by Rayhaneh Pharmaceutical Company
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The weight range of participating candidates should be between 60-100 kg Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (γ-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose Volunteers who have agreed to an informed consent form All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw
Exclusion criteria:
History of allergic or adverse reaction to Azithromycin or any similar product Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg Smokers Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s)
Age
From 18 years old to 60 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope after entering the study, and numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of the both groups will change for the second period.
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 of Tabriz University of Medical Sciences
Street address
Daneshghah St. Drug Applied Research Center
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.TBZMED.REC.1402.549

Health conditions studied

1

Description of health condition studied
Bioequivalence study in healthy volunteers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plasma concentration of the drug
Timepoint
15 sampling time included pre-dose (time 0) and at the following hours post-dose: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, and 48 h
Method of measurement
Liquid Chromatography with tandem mass spectrometry (LC-MS-MS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In this group, volunteers are given a single oral dose of Empagliflozin tablet 25 mg produced by Rayhaneh Co. (Domestic). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 2.
Category
N/A

2

Description
Intervention group 2: In this group, volunteers are given a single oral dose of Empagliflozin tablet 25 mg (Jardiance®), produced by Boehringer Ingelheim Company (Brand). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 1.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Drug Applied Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rayhaneh Pharmaceutical Company
Full name of responsible person
Yahya hazaei
Street address
2nd floor, No. 5., Parvaneh St.,Jalal Al Ahmad,Tehran St
City
Tehran
Province
East Azarbaijan
Postal code
1439915481
Phone
+98 21 5765 5000
Email
info@rayhanehpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rayhaneh 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
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/

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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