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In-vivo Bioequivalence Test of Rosuvastatin tablets in comparison with brand name drug (CRESTOR® 20mg F.C Tab.) Made by ASTRA-Zeneca, UK.

Protocol summary

Study aim
In- Vivo Bioequivalence study of Rosuvastatin tablet 20mg Hakim with brand drugs (CRESTOR® 20mg, ASTRA-ZENECA, Belgium) in Iranian healthy volunteers.
Design
Single dose, randomized, two sequences, two period crossover with a washout period.
Settings and conduct
This study will be conducted in two-way, cross-over and fasting, and on two sets of healthy volunteers. The study will be conducted in two periods of twenty-four hours.The interval between these two periods, which is called the wash-out time, is determined by the half-life of the drug plasma, which according to scientific sources should be at least 5 to 7 half-life of the drug in the case of the drug under study. The plan will take a week to clean up the drug, given the biological half-life of the drugs in the drug form.In the first round, candidates are divided into two groups, and the first group receives a test tablet and the second group receives a similar tablet. Blood samples will taken by the volunteer by the technician immediately after taking the drug, and the preparation steps of the samples, including plasma separation and drug extraction, are performed to analyze the amount of drug on them.
Participants/Inclusion and exclusion criteria
24 participants will be selected from non-smoking, not pregnant people with no history of heart, kidney and liver disease or dis functions with both sex (male&female). The ages and BMIs of participant should be in the range of 18-60 and 18-25 respectively.
Intervention groups
Both groups received in cross-over design medication and testing at two different cross-sections and Therefor,the test results are independent of individual differences and it will only show the difference in the formulation of the two drugs.
Main outcome variables
Maximum plasma concentration of the drug, time to reach the maximum plasma concentration, drug excretion half-life, drug excretion constant

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200105046010N11
Registration date: 2020-10-24, 1399/08/03
Registration timing: prospective

Last update: 2020-10-24, 1399/08/03
Update count: 0
Registration date
2020-10-24, 1399/08/03
Registrant information
Name
Javad Shokri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3661 4125
Email address
shokri.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-03, 1399/10/14
Expected recruitment end date
2021-07-05, 1400/04/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In-vivo Bioequivalence Test of Rosuvastatin tablets in comparison with brand name drug (CRESTOR® 20mg F.C Tab.) Made by ASTRA-Zeneca, UK.
Public title
In-vivo Bioequivalence Test of Rosuvastatin tablets with brand name drug CRESTOR® 20mg F.C Tab. Made by ASTRA-Zeneca, UK in Iranian healthy volunteers.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health Body mass index(18-28) Informed consent Age(18-60)
Exclusion criteria:
Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug
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)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Candidates are not aware of the test drug or brand name. In a one-blind study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Rosuvastatin and Rosuvastatin ® 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
Tabriz University of Medical Sciences Ethics Committee
Street address
No.48,Ferdows street, Ferdowsi Sq.
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Approval date
2020-09-27, 1399/07/06
Ethics committee reference number
IR.TBZMED.REC.1399.666

Health conditions studied

1

Description of health condition studied
In this study, the disease is not examined. Subject bioequivalence test and reference tablets Razvvastatyn studied.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination of blood drug concentration.
Timepoint
Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours.
Method of measurement
High Performance Liquid Chromatography with tandem mass spectroscopy detector

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Single dose Rosuvastatin tablet 20mg Hakim Pharmaceutical Company.
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
Tabriz University of Medical Sciences
Full name of responsible person
Mehrdad alimiyan
Street address
Dr. Ali Shariati St., Gholhak Intersection, No. 1991, Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1913774951
Phone
+98 21 2226 3051
Email
info@hakimpharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences.
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences.
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences.
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@gmail.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 date are as secure between researcher and related industries.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only protocol and methods of study are sharable.
When the data will become available and for how long
After finishing of the protocol (Probably 6 months receiving IRCT code)
To whom data/document is available
Pharmaceutical and medical sciences researchers.
Under which criteria data/document could be used
Projects information's for any publications is not allowed.
From where data/document is obtainable
Contact with E-mail of the main researcher.
What processes are involved for a request to access data/document
Personal and academic details and the aim of the request.
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