Bioequivalence Study of Ticagrelor 90mg tablet manufactured by Kimia Ara Heram company versus originator brand (Brilinta 90) manufactured by Astrazenica company
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 (48h). The interval between these two periods is one week. In the first round of the study, the candidates divide into two groups and the first group receives a test's tablet and the second group receives a brand's tablet. Blood samples are collected immediately before and after drug administration by volunteers. Then, plasma separation and drug extraction are done and samples are ready for analysis.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-55 years old)
Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcoholism and Narcoticism, History of allergy to Ticagrelor
Intervention groups
Intervention group 1: Brilinta 90 tablet as a reference
Intervention group 2: Brelor 90 tablet as a test
Main outcome variables
Maximum drug concentration, Time to reach maximum drug concentration, Half-life of drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047902N9
Registration date:2021-11-07, 1400/08/16
Registration timing:prospective
Last update:2021-11-07, 1400/08/16
Update count:1
Registration date
2021-11-07, 1400/08/16
Registrant information
Name
Elham Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 5196
Email address
ghasemian@zistdaru.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-06, 1400/09/15
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Ticagrelor 90 ( Brelor)manufactured by Kimia Ara Heram versus originator brand in healthy volunteers in fasting condition
Public title
Bioequivalence study of Ticagrelor 90mg
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart, and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-55 years old)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Alcoholism and Narcoticism
History of allergy to Ticagrelor
Age
From 18 years old to 50 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
16
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:Kimia Ara Heram's medicine ) and the second 12 no.s are considered as (second 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). Kimia Ara Heram's Ticagrelor 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
کمیته اخلاق در پژوهش دانشگاه علوم پزشکی تبریز
Street address
2nd floor, No.27, Sharifi St., North Gandhi Ave.
City
Tehran
Province
Tehran
Postal code
1969813633
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.TBZMED.REC.1400.637
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 32, 48 h after drug administration
Method of measurement
LC -MASS-MASS
Secondary outcomes
1
Description
Pharmacokinetic parameters
Timepoint
After intervention
Method of measurement
Theoretical and pahrmacokinetic equations
Intervention groups
1
Description
Intervention group: single dose, one oral tablet 90mg (Brilinta) manufactured by Astrazenica, as reference product
Category
Treatment - Drugs
2
Description
Intervention group: Single dose, one oral tablet of Brelor 90 mg manufactured by Kimia Ara Heram company as test product
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Simin Baspar Teyf Gostar Company
Full name of responsible person
Javad Shokri
Street address
No.48, Ferdos Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Email
Shokri.j@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kimia Ara Heram company
Full name of responsible person
Omid Rahbar Safa
Street address
2nd fllor, No.27, Sharifi St., North Gandhi Ave.
City
Tehran
Province
Tehran
Postal code
1969813633
Phone
+98 21 8820 1734
Email
info@kimiara.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kimia Ara Heram 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
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visitingprofessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
2nd floor, No. 27, Sharifi St., North Gandhi Ave.
City
Tehran
Province
Tehran
Postal code
1969813633
Phone
+98 21 8820 1734
Email
ghasemian_elham@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visitingprofessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
2nd floor, No. 27, Sharifi St., North Gandhi Ave.
City
Tehran
Province
Tehran
Postal code
1969813633
Phone
+98 21 8820 1734
Email
ghasemian_elham@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visitingprofessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
2nd floor, No. 27, Sharifi St., North Gandhi Ave.
City
Tehran
Province
Tehran
Postal code
1969813633
Phone
+98 21 8820 1734
Email
ghasemian_elham@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
These data are secure between researchers and related industries.