In vivo Fasted state Bioequivalence study of Rosuvastatin 40 mg tablet compared to innovator product
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 40mg 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
Inclusion criteria: General Health (Liver, Heart and Kidney), Age (18-60)
Exclusion criteria: Smoking, History of cardiovascular disease, liver and kidney disease, Pregnancy, Alcohol and drug addiction, History of drug allergy
Intervention groups
Intervention group will receive one test drug product. Blood samples will be taken from the volunteers for 48 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector.
Control group will receive one reference drug product. Blood samples will be taken from the volunteers for 48 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector.
Main outcome variables
Drug plasma concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210519051345N11
Registration date:2022-05-12, 1401/02/22
Registration timing:prospective
Last update:2022-05-12, 1401/02/22
Update count:0
Registration date
2022-05-12, 1401/02/22
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
2022-05-20, 1401/02/30
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In vivo Fasted-State Bioequivalence Study of Rosuvastatin 40 mg Tablet Compared to Innovator Product
Public title
Investigating In vivo Bioequivalence of Rosuvastatin Tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart and Kidney)
Exclusion criteria:
Smoking,
History of cardiovascular disease, liver and kidney disease,
Pregnancy,
Alcohol and drug addiction,
History of drug allergy
Age
From 18 years old to 60 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The order of receiving the test product or reference for each subject in each time period will be determined based on the randomization program. The randomization program will be developed using randomization software based on the number assigned to each subject. The number assigned to each subject will be based on the priority of being on the list of subjects for screening.
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
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishabouri st., Golgasht.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.TBZMED.REC.1401.127
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
.5-48 hours in predetermined time intervals after drug administration
Method of measurement
HPLC (High performance liquid chromatography)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will receive one test drug product. Blood samples will be taken from the volunteers for 48 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector.
Category
Treatment - Drugs
2
Description
Control group: Control group will receive one reference drug product. Blood samples will be taken from the volunteers for 48 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector.
Category
Treatment - Drugs
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
Tabriz University of Medical Sciences, Faculty of Pharmacy, Golgasht st Attar Neishaboori st.
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
Parviz Shahabi
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 3334 8801
Email
shahabip@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kimidaru 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
Persons
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
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishabouri st., Golgasht.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
+98 41 3334 4798
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
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishabouri st., Golgash.t,
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
+98 41 3334 4798
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 of Biopharmacy and Pharmacokinetics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishabouri st., Golgasht. ,
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
+98 41 3334 4798
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