In vivo Bioequivalence study of Tcagrelor 90 mg Tablet
Design
Twenty four healthy male volunteer will enter the study based on random numbers table as two groups of twelve people. Each volunteer will receive a single dose of drug in two periods. In one period the test formulation and in another period the reference formulation (without knowing the formulation identity in each period). Therefore each volunteer will be his own "Control".
Settings and conduct
After administration of one 90 mg tablet to volunteer, the blood samples will be taken in predetermined time intervals up to 48 hours. The samples will be stored in freezer -4 degrees centigrade until analysis and sample quantitation. In this study the volunteer would not be aware of the formulation identity in each period.
Participants/Inclusion and exclusion criteria
Healthy Male Volunteers without any Heart, Liver and Kidney Diseases
Intervention groups
Each volunteer will receive a single dose of drug in two periods. In one period the test formulation and in another period the reference formulation. Therefore each volunteer will be his own "Control".
Main outcome variables
Being/not being bioequivalence between two products based on FDA guidelines
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210519051345N1
Registration date:2021-06-14, 1400/03/24
Registration timing:prospective
Last update:2021-06-14, 1400/03/24
Update count:0
Registration date
2021-06-14, 1400/03/24
Registrant information
Name
Parvin Zakeri-Milani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 8801
Email address
pzakeri@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-21, 1400/05/30
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In vivo Bioequivalence study of Ticagrelor 90 mg Tablet manufactured by Sobhan Daroo Co. on 24 volunteers compared with reference product
Public title
In vivo Bioequivalence study of Ticagrelor Tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Being Healthy without any Heart, liver and kidney diseases
Exclusion criteria:
Having any kind of illnesses
Age
From 25 years old to 55 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Using the Table of Random Numbers
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, Volunteers participating will be blinded to the type of product they are taking in each period (test or reference product). This means that the product will be given to the volunteers for administration outside the original packaging
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Committe, Tabriz University of Medical Sciences
Street address
Golgasht st. Attar Neishabouri st. Faculty of Pharmacy, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Approval date
2021-05-17, 1400/02/27
Ethics committee reference number
IR.TBZMED.REC.1400.164
Health conditions studied
1
Description of health condition studied
In the present study, no diseases will be examined and products will be administered by healthy volunteers.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma Drug Concentration
Timepoint
0.5-48 hours in predetermined time intervals
Method of measurement
HPLC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Healthy volunteers
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Pharmacy Tabriz University of Medical Sciences
Full name of responsible person
Parvin Zakeri-Milani
Street address
Golgasht st. Attar Neishaboori st. Faculty of Pharmacy, Tabriz University of Medicl Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
pzakeri@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
No.2 Central Building 3rd Floor, Daneshgah st. Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sobhan Daroo Co.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Zakeri-Milani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golgasht st Attar Neishaboori st, Faculty of Pharmacy, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
pzakeri@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Zakeri-Milani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Gogasht st., Attar Neishaboori st., Faculy of Pharmacy, Tabriz University of Medical Siences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
009841133348801
Email
pzakeri@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Zakeri-Milani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Golgasht st., Attar Neishaboori St., Faculty of Pharmacy, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
pzakeri@tbzmed.ac.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
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available