Comparative bioequivalence Study of the Eltrombopag 50 mg Tablets, Manufactured by Arang Daroo Darman Pharmaceutical Company by Innovative Company (Revolade)
Comparison Bioequivalence study of Eltrombopag 50 mg tablets produce by Daroo Darman Arang Pharmaceutical Company and Its the brand Product
Design
This study is a single-blind crossover study with two intervention groups of 12, randomized by the Rand function of SPSS software. The sample size is 24, randomly selected and randomly divided into two groups.
Settings and conduct
In this study, which will be conducted at the Tabriz Bioassay Drug Monitoring Laboratory, there are two intervention groups that have been randomized using the Rand function of SPSS software. The first and second groups will take the Iranian and brand-name drugs, respectively, without knowing it, and blood will be drawn at specific intervals. Since it is one-sided, this procedure will be repeated after a washout period and the equivalence of the drugs will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: General health (liver, heart, and kidney)
Body mass index between 18 and 28)
Informed consent
Age between 18-60 years
Exclusion criteria:
Smoking
History of cardiovascular disease
Pregnancy
Alcohol and drug addiction
History of allergy to this drug
Intervention groups
In this study, there are two intervention groups, the first and second groups taking Iranian and branded drugs, respectively. After a cleansing period, this process is reversed and the equivalence of the drugs is examined based on blood concentrations taken at specific times.
Main outcome variables
Drug Concentration
General information
Reason for update
Acronym
None
IRCT registration information
IRCT registration number:IRCT20231108059993N8
Registration date:2025-10-23, 1404/08/01
Registration timing:prospective
Last update:2025-10-23, 1404/08/01
Update count:0
Registration date
2025-10-23, 1404/08/01
Registrant information
Name
Iran Ghanbarzadeh
Name of organization / entity
Alborz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 3383 2649
Email address
s_ghanbarzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-05, 1404/08/14
Expected recruitment end date
2025-11-19, 1404/08/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence Study of the Eltrombopag 50 mg Tablets, Manufactured by Arang Daroo Darman Pharmaceutical Company by Innovative Company (Revolade)
Public title
Comparative bioequivalence study of the Eltrombopag 50 mg Tablets, Manufactured by Daroo Darman Arang Pharmaceutical Company
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Must be in good general health (liver, heart, and kidneys).
Body mass index should be in the range of 18-28.
Informed consent must be obtained.
Age must be between 18-60 years.
Exclusion criteria:
History of allergic or adverse reaction to eltrombopag or any similar product.
Addiction to cigarettes, alcohol, or any type of drug
Volunteers with a history of chronic diseases such as high blood pressure or high blood lipids, etc. who have taken medication in the past two months.
Age
From 18 years old to 60 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals in the age group mentioned are invited to participate through an advertisement. Then, individuals are checked for health and healthy volunteers are identified. Each volunteer is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. Then, balls are randomly removed from the container. The first 12 people are considered as (sequence one: recipients of elentrombopag 50) and the second 12 people are considered as (sequence two: recipients of rovalipin 50). The participating volunteers are unaware of receiving the test drug or the brand drug.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blind (participant) clinical trial. Eltrombopag tablets are removed from their packaging by the investigator and placed in identical, coded containers. Volunteers are unaware of the type of drug they are taking in each series of the experiment.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ،Tabriz University of Medical Sciences
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences Daneshgah St. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5167698354184
Approval date
2025-10-06, 1404/07/14
Ethics committee reference number
IR.TBZMED.REC.1404.526
Health conditions studied
1
Description of health condition studied
Healthy volunteer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
At specific intervals, the blood concentration of the drug is measured and compared in two series of blood draws, and it is determined whether the drugs are equivalent or not.
Timepoint
Drug concentrations are measured at time intervals of 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 48, and 72 hours after drug administration.
Method of measurement
Liquid chromatography with dual mass spectrometer LC/MS/MS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 receives an Iranian drug and blood concentrations are obtained at specific time intervals. In the second series, this group receives the brand name drug.
Category
Other
2
Description
The intervention group receives 2 brand drugs and blood concentrations are obtained at specific intervals. In the second series, this group receives the Iranian drug. Finally, the results obtained from the two intervention groups are compared and it is determined whether they are equivalent or not.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Payesh Daroo Zist Azma
Full name of responsible person
Saeed Ghanbarzadeh
Street address
No 10, Ave Mehrab, Ave Mirdamad
City
Tabriz
Province
East Azarbaijan
Postal code
5186733653
Phone
+98 41 3383 2649
Email
s_ghanbarzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arang Daroo Darman
Full name of responsible person
Alireza Mahbobian
Street address
Sheikh bahaee, Molla sadra
City
Tehran
Province
Tehran
Postal code
5166934184
Phone
+98 41 3383 2649
Fax
Email
Info@Arangpharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arang Daroo Darman
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
Phayesh Daroo Zist Azma
Full name of responsible person
Saeed Ghanbarzadeh
Position
Ph.D of Pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 10, Ave Mehrab, Ave Mirdamad
City
Tabriz
Province
East Azarbaijan
Postal code
5166934184
Phone
+98 41 3383 2649
Email
s_ghanbarzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arang ِDaroo Darman
Full name of responsible person
Saeed Ghanbarzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 10, Mehrab, Ave, Mirdalad Ave
City
Tabriz
Province
East Azarbaijan
Postal code
۱۹۹۳۶۷۴۸۵۵
Phone
+98 21 8806 4460
Email
s_ghanbarzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
َSaeed Ghanbarzadeh
Position
Associated Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
No 10, Mehrab Ave, Mirdamad Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166934184
Phone
+98 41 3383 2649
Email
s_ghanbarzadeh@yahoo.com
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
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
None
When the data will become available and for how long
None
To whom data/document is available
None
Under which criteria data/document could be used
None
From where data/document is obtainable
None
What processes are involved for a request to access data/document