In-vivo Bioequivalence Study of Linagliptin/Metformin 2.5/1000 mg FC. Tablets of The Test Drug (Kharazmi Pharma, Iran) in Compared with The Reference Drug (Jentadueto® 2.5/1000 mg, Boehringer Ingelheim, Germany) in fasting condition in healthy volunteers
In-vivo Bioequivalence Study of Linagliptin/Metformin 2.5/1000 mg FC. Tablets of The Test Drug (Kharazmi Pharma, Iran) in Compared with The Reference Drug (TRAJENTA DUO® 2.5/1000 mg, Boehringer Ingelheim, Germany) in fasting condition in healthy volunteers.
Design
Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct
The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (72h). The interval between these two periods is two week. The candidates were divided into two groups in the first round of the study. the first group receives a test tablet and the second group receives a brand tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin Laboratory in Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion criteria: General Health (Liver, Heart, and Kidney); Body Mass Index (18-28 kg/m^2); Informed consent; age (18-55 years old). Exclusion criteria: smoking; history of cardiovascular disease; history of liver and kidney disease; alcohol and drug addiction; history of allergy to Linagliptin or Metoformin
Intervention groups
Intervention group 1: TRAJENTA DUO® 2.5/1000 mg tablet as a reference Intervention group 2: Linagliptin/Metformin 2.5/1000 mg as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N101
Registration date:2024-03-03, 1402/12/13
Registration timing:prospective
Last update:2024-03-03, 1402/12/13
Update count:0
Registration date
2024-03-03, 1402/12/13
Registrant information
Name
Javad Shokri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3661 4125
Email address
shokri.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2025-04-21, 1404/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In-vivo Bioequivalence Study of Linagliptin/Metformin 2.5/1000 mg FC. Tablets of The Test Drug (Kharazmi Pharma, Iran) in Compared with The Reference Drug (Jentadueto® 2.5/1000 mg, Boehringer Ingelheim, Germany) in fasting condition in healthy volunteers
Public title
Bioequivalence Study of Linagliptin/Metformin 2.5/1000 mg FC. Tablets of The Test Drug (Kharazmi Pharma, Iran)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28) kg/m^2
Informed consent
Age (18-55 years old)
Exclusion criteria:
Nicotine consumption history
Cardiovascular disease History
Liver and kidney disease History
Alcohol and opioid addiction
Allergy reactions history to Linagliptin or Metformin
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
28
Blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. The balls are then removed randomly from the container. The first 12 no.s are considered as (first sequence: Kharazmi's medicine ) and the second 12 no.s are considered as (first sequence: originator brand recipient). The volunteers don't have any information about taking the test drug or brand drug
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Test and Originator brand's tablets are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences ethics committe
Street address
Research and technology deputy,3rd floor, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.TBZMED.REC.1402.794
Health conditions studied
1
Description of health condition studied
This study is performed on healthy volunteers and drug concentration in plasma is determined.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
0، 1، 1.5، 2، 2.5، 0،3، 3.5، 4.0، 6.0، 8، 10، 12، 24، 48 72 h after drug administration
Method of measurement
Liquid Chromatography Mass-Mass
Secondary outcomes
1
Description
Time to reach maximum plasma concentration
Timepoint
After intervention
Method of measurement
Time to reach the maximum drug concentration in plasma is recorded.
2
Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time
Intervention groups
1
Description
Intervention group:Single dose, one oral The Reference Drug (TRAJENTA DUO® 2.5/1000 mg, Boehringer Ingelheim, Germany). after washout period, the volunteers receive Linagliptin/Metoformin 1000/2.5 tablet manufactured by Kharazmi Co.
Category
Treatment - Drugs
2
Description
Intervention group: Single dose, one oral Linagliptin/Metoformin 1000/2.5 mg tablet manufactured by Kharazmi company as test product.after washout period, the volunteers receive TRAJENTA DUO® 2.5/1000 mgBoehringer Ingelheim, Germany