Comparative bioequivalence study of Sitagliptin 100 mg tablet of Actoverco. and Januvia 100 mg tablet of Merck as reference in 24 healthy male under fasting.
This study will be performed to compare the pharmacokinetics and invivo parameters of Sitagliptine 100 mg tablet formulation as a test product with Januvia 100 mg formulation as a reference product and to evaluate the bioequivalence of these two formulations.
Design
Non blinded, randomized, crossover in vivo bioequivalence study in 24 healthy male under fasting condition.
Settings and conduct
In each period, volunteers will receive a single dose intervention (1 or 2) in the Farabi Clinic (Eslamshahr, Tehran).17 blood samples were collected during 72 hours post intervention. A 7-day washout interval separated to study periods.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy subjects (male) between 20 – 45 years of age and Body Mass Index (BMI) within 15% of normal range according to the accepted normal values between 18.5 and 30 (inclusive), calculated as kg/m2.
Exclusion criteria: Hypersensitivity to the Dipeptidyl peptidase 4 inhibitors, investigational drug and/or inactive ingredients.
Subjects who has used any drug including prescription or Over-The-Counter (OTC) within 14 days prior to the start of the study and might need drug intake during study period.
Intervention groups
Intervention group 1: Sitagliptin 100 mg Tablet , produced by Actoverco is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product. Intervention group 2: Januvia 100 mg tablet , produced by Merck 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:IRCT20180620040164N27
Registration date:2022-05-22, 1401/03/01
Registration timing:prospective
Last update:2022-05-22, 1401/03/01
Update count:0
Registration date
2022-05-22, 1401/03/01
Registrant information
Name
Soheil Famili
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
2022-06-06, 1401/03/16
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Sitagliptin 100 mg tablet of Actoverco. and Januvia 100 mg tablet of Merck as reference in 24 healthy male under fasting.
Public title
Comparative in vivo evaluation of 2 Sitagliptin 100 mg Tablet formulations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) between 20-45 years of age.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Subjects with normal vital signs.
Subjects who agree with patient consent form.
Body Mass Index (BMI) within 15% of normal range 18.5 and 30 (inclusive), calculated as kg/m2.
Exclusion criteria:
Hypersensitivity to the DPP-4 inhibitors, investigational drug and/or to inactive constituents.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Subjects who has used any drug including prescription or Over-The-Counter (OTC) drugs within 14 days prior to the start of the study and might need drug intake during study period.
History of alcohol or drug abuse within 2 years before the start of the study.
Heavy drinker of caffeine, or caffeinated drinks.
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.
Heavy drinker of grapefruit juice
Subjects on special diet (such as vegetarians)
Subjects who do exertional physical activity.
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's number (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 of School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Medica
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2021-08-10, 1400/05/19
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.112
Health conditions studied
1
Description of health condition studied
Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 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
17 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 9, 10, 12, 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 group 1: Sitagliptin 100 mg tablet, produced by Actoverco is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-day wash-out period the intervention 2 will be given to these subjects.
Category
Treatment - Drugs
2
Description
Intervention group 2: Januvia 100 mg tablet, produced by Merck is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 7-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
Hakim Farabi Clinic
Full name of responsible person
Ebrahim Siahpoosh
Street address
No. 57, Shemshad alley, in front of Sallor town.
City
Tehran
Province
Tehran
Postal code
4635314588
Phone
+98 21 9253 5647
Email
partochem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Actover Pharmaceutical Co.
Full name of responsible person
Dr. Ramin Daneshmir
Street address
No. 58, 8th St., Gisha
City
Tehran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4162 7000
Email
info@actoverco.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?