This study will be performed to compare the pharmacokinetics and invivo parameters of Linagliptin 5 mg Tablet formulation as a test product with Trajenta 5 mg Tablet 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 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 21-day washout period.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2. Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations. Exclusion Criteria: Known hypersensitivity to linagliptin or inactive ingredients. Acute infection within one week preceding first study drug administration.
Intervention groups
Intervention group 1: Linagliptin 5 mg Tablet, produced by Dorsa 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: Trajenta 5 mg Tablet, produced by Boehringer 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:IRCT20180620040164N65
Registration date:2024-06-19, 1403/03/30
Registration timing:prospective
Last update:2024-06-19, 1403/03/30
Update count:0
Registration date
2024-06-19, 1403/03/30
Registrant information
Name
Behzad Montaha Sangari
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
2024-08-26, 1403/06/05
Expected recruitment end date
2024-09-16, 1403/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of َLinagliptin 5 mg Tablet of Dorsa Pharmaceutical Co. and Trajenta of Boehringer as reference in 24 healthy male under fasting.
Public title
Comparative in vivo evaluation of 2 َLinagliptin 5 mg Tablet formulations.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy subjects (male) between 18 – 45 years of age and Body Mass Index (BMI) between 18.5 and 30 (inclusive), calculated as kg/m2.
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.
Exclusion criteria:
Known hypersensitivity or idiosyncratic reaction to Linagliptin or inactive ingredients.
Acute infection within one week preceding first study drug administration. Subject has a history of severe diseases which have direct impact on the study.
Smoking more than 10 cigarettes per day and could not tolerate cigarette cessation during each clinical period.
Subjects who have 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.
Subjects who have a history of alcohol or substance abuse within the last 5 years.
Heavy drinker of alcohol, grapefruit juice or caffeinated drinks or who are on special diet (such as vegetarians) or do exertional physical activity.
Subject intends to be hospitalized within 3 months after first study drug administration.
Subjects who, through completion of this study, would have donated more than 500 ml of blood in 7 days.
Age
From 18 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.1403.037
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 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 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
15 blood samples will be withdrawn pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 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: Linagliptin 5 mg Tablet , produced by Dorsa Pharmaceutical Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 21-day wash-out period the intervention 2 will be given to these subjects.
Category
Treatment - Drugs
2
Description
Intervention group 2: Trajenta 5 mg tablet, produced by Boehringer is the reference product. In each period, 12 of 24 subjects will be given single oral dose of this product. After 21-day wash-out period the intervention 1 will be given to these subjects.