Randomized, single-dose, crossover comparative bioequivalence study of Linagliptin 5 mg tablets of Alhavi pharmaceutical co. and Boehringer in 24 healthy male under fasting conditions
Bioequivalence study of Linagliptin 5 mg tablets of Alhavi pharmaceutical co. and Trajenta 5 mg tablet of Boehringer.
Design
Randomized, single-dose, crossover comparative bioequivalence study of Linagliptin 5 mg tablets of Alhavi Pharmaceutical Co. and Boehringer in 24 healthy male under fasting conditions
Settings and conduct
Study place: Hakim Farabi Clinic.
Place for Blood and plasma sample analysis: Radin laboratory, Tabriz.
Twenty four healthy male volunteers received each of two test or reference Linagliptin tablets in random sequence according to the randomization schedule. Receiving drug periods were 5 weeks apart from each other and after the washout period, subjects received the other product. Blood samples were taken from all participants before receiving the drug and 72 hours after that at determined time points for pharmacokinetic evaluations.
Participants/Inclusion and exclusion 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.
• Known hypersensitivity to linagliptin or inactive ingredients.
• Subjects with a known history of allergic reaction.
Intervention groups
Intervention group 1 (test): Linagliptin 5 mg tablet, produced by Alhavi pharmaceutical co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Intervention group 2 (Reference): Linagliptin 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.
Main outcome variables
Cmax, AUC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180620040164N4
Registration date:2020-08-04, 1399/05/14
Registration timing:retrospective
Last update:2020-08-04, 1399/05/14
Update count:0
Registration date
2020-08-04, 1399/05/14
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
2020-05-04, 1399/02/15
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized, single-dose, crossover comparative bioequivalence study of Linagliptin 5 mg tablets of Alhavi pharmaceutical co. and Boehringer in 24 healthy male under fasting conditions
Public title
Bioequivalence study of Linagliptin 5 mg tablets in 24 healthy male under fasting conditions
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 ECG and vital signs.
Subjects who agree with patient consent form.
Exclusion criteria:
Known hypersensitivity to linagliptin or inactive ingredients
Acute and chronic cardiovascular, respiratory, gastrointestinal diseases, neuroendocrine disorders, blood system disorders and renal or hepatic impairment
Acute infectious diseases less than 1 weeks prior to the start of the study
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
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
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
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
More than 1 sample in each individual
Number of samples in each individual:
26
In each period, 13 blood samples are collected from each subject and this study includes 2 periods.
Randomization (investigator's opinion)
Randomized
Randomization description
The order of receiving the test product or reference for each subject in each time period was determined based on the randomization program. The randomization program was developed using randomization software based on the number assigned to each subject. The number assigned to each subject was based on the priority of being on the list of subjects for screening.
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 Shahid Beheshti University of Medical Sciences
Street address
7th Floor, Builing No.2, Shahid Beheshti University of Medical Sciences, Arabi Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2020-05-31, 1399/03/11
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1399.046
Health conditions studied
1
Description of health condition studied
Bioequivalence investigation of the generic (Alhavi pharmaceutical co.) Linagliptin 5 mg tablet with brand (Boehringer) Trajenta 5 mg tablet.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
During 2 months 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
During 2 months 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: Intervention group (test): Linagliptin 5 mg tablet, produced by Alhavi pharmaceutical co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
2
Description
Intervention group (Reference): Linagliptin 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.
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, Sallor city
City
Eslamshahr
Province
Tehran
Postal code
4635314588
Phone
+98 21 5647 9253
Email
mina.hasanabadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alhavi pharmaceutical co.
Full name of responsible person
Mohamad masoud Alimorad
Street address
12 km of Karaj road
City
Tehran
Province
Tehran
Postal code
141551538
Phone
+98 21 4490 5056
Email
info@alhavipharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Alhavi pharmaceutical co.
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
Noor Research & Development Institute
Full name of responsible person
Ali Aghaei
Position
master
Latest degree
Master
Other areas of specialty/work
pharmacy
Street address
Unit 34, No. 69, Habibzadegan Ave., Teymuri St.,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Seyed Mohsen Foroutan
Position
Principal investigator
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Unit 34, No. 69, Habibzadegan Ave., Teymuri St.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir
Person responsible for updating data
Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Ali Aghaei
Position
master
Latest degree
Master
Other areas of specialty/work
pharmacy
Street address
Unit 34, No. 69, Habibzadegan Ave., Teymuri St.
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available