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Comparative bioequivalence study of the Sitagliptin 50 mg/ Metformin 1000 mg Tablets manufactured by Raha Pharmaceutical Company

Protocol summary

Study aim
Examining the bioequivalency of domestically produced Sitagliptin / Metformin tablet with brand samples(Janumet®)
Design
A crossover, not blinded, randomized, bioequivalence clinical trial on 24 healthy volunteers.
Settings and conduct
Study place: Drug Applied Research Center affiliated to Tabriz University of Medical Science. The number of 24 volunteer in the age range of 18-50 years and the Body Mass Index range of 18-30. A Sitagliptin 50 mg/ Metformin 1000 mg tablet is taken fasting and blood is taken at 17 times point. One week later, the process is repeated for the brand medicine.
Participants/Inclusion and exclusion criteria
The weight range of participating candidates should be between 60-100 kg. All candidates must be non-smokers. 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.
Intervention groups
After taking a Sitagliptin 50 mg/ Metformin 1000 mg tablet from domestic company, 3 milliliters of blood will be collected from the volunteer in 17 times intervals for 72 hours. One week later, the process is repeated for a brand sample tablet. The drug concentration is measured in plasma
Main outcome variables
Studying the Drug pharmacokinetic parameters including measuring the plasma concentrations for brand and test products, determining the desired and important pharmacokinetic parameters in bioequivalence studies, AUCs, Tmax, Cmax, T1/2.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130313012810N34
Registration date: 2024-07-05, 1403/04/15
Registration timing: registered_while_recruiting

Last update: 2024-07-05, 1403/04/15
Update count: 0
Registration date
2024-07-05, 1403/04/15
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
2024-07-05, 1403/04/15
Expected recruitment end date
2024-07-06, 1403/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of the Sitagliptin 50 mg/ Metformin 1000 mg Tablets manufactured by Raha Pharmaceutical Company
Public title
Sitagliptin / Metformin tablet Bioequivalence
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The weight range of participating candidates should be between 60-100 kg. Volunteers 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 Sitagliptin or metformin or any similar product. Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg. Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s). Smokers.
Age
From 18 years old to 50 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
2024-01-14, 1402/10/24
Ethics committee reference number
IR.TBZMED.REC.1402.784

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
17 sampling time till 72 h
Method of measurement
Liquid Chromatography with tandem mass spectrometry (LC-MS-MS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Intervention group 1, which consists of 24 healthy and fasting volunteers, will receive a tablet with a dose of 50/1000 mg manufactured by Raha Pharmaceutical Company.
Category
Other

2

Description
Intervention group 2: Intervention group 2, which consists of 24 healthy and fasting volunteers, will receive a tablet with a dose of 50/1000 mg manufactured by Dohme (MSD) Pharmaceutical Company.
Category
Other

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
Raha Pharmaceutical Company
Full name of responsible person
Akram Sharifian
Street address
Unit 11, Sofeh Industrial Town, km 7 of Shiraz Road, Isfahan
City
Esfahan
Province
Isfehan
Postal code
81791 35148
Phone
+98 31 3654 0659
Email
int@rahapharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Raha 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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