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A randomized, open label, two treatments, two periods, single dose, crossover, bioequivalence study of Rosuvastatin 20mg tablet of Tolidarou Pharm Co., IRAN in comparison of Crestor 20mg tablet of Astra-Zeneca in 24 healthy subjects under fasting condition

Protocol summary

Study aim
- Bioequivalence study of single dose of test formulation (Rosuvastatin 20mg tablet) in comparison of reference product (Crestor 20mg tablet) by means of AUC0-t and Cmax in healthy, adult human subjects under fasting conditions.
Design
A randomized, open label, two treatments, two periods, single dose, crossover, bioequivalence study of Rosuvastatin 20mg tablet of Tolidarou Pharm Co., IRAN in comparison of Crestor 20mg tablet of Astra-Zeneca in 24 healthy subjects under fasting condition
Settings and conduct
1- 24 healthy subjects enroll in this project. Volunteers provide written informed consent. 2- A single dose of 2 tablets of rosuvastatin 20 mg will administer, in each study period. 3-The Blood samples collect before and at 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 6.0, 8.0, 10.0, 24.0 & 48.0 hr. after dosing. 4- The treatment phases separate by a washout period of at least 7 days. 5- Drug Prescription and sampling take place in Core Research Lab. of Zahedan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Main Inclusion criteria: Healthy subjects aged between 18 -50 years old and weighted between 50 – 100 kg\\ Main exclusion criteria: Clinically relevant deviations from normal (BMI less than 18 and more than 25); Donation a unit of blood or participated in another clinical trial within the last three months; History of drug or alcohol abuse; Used any medication within 7- 14 days before the first treatment; History of allergic to statins
Intervention groups
Intervention: Single dose of 2 tablets of Rosuvastatin 20mg of Tolidarou Pharm Co., IRAN Control: single dose of 2 tablets of Crestor 20mg of Astra-Zeneca
Main outcome variables
Plasma concentration of rosuvastatin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190706044111N16
Registration date: 2020-03-07, 1398/12/17
Registration timing: retrospective

Last update: 2020-03-07, 1398/12/17
Update count: 0
Registration date
2020-03-07, 1398/12/17
Registrant information
Name
Ladan Tayebi
Name of organization / entity
Pars Biopharmacy Research Co.
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 6061
Email address
l.tayebi@parsbiopharmacy.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
1978-04-21, 1357/02/01
Expected recruitment end date
1979-03-20, 1357/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized, open label, two treatments, two periods, single dose, crossover, bioequivalence study of Rosuvastatin 20mg tablet of Tolidarou Pharm Co., IRAN in comparison of Crestor 20mg tablet of Astra-Zeneca in 24 healthy subjects under fasting condition
Public title
Bioequivalence study of Rosuvastatin 20mg tablet of Tolidarou Pharm Co., IRAN
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
- Aged between 18 - 50 years - - Body weight between 50 – 100 kg - Having good health on the basis of medical history and physical & clinical examination Understand the procedures and give written informed consent
Exclusion criteria:
Subject with BMI less than 18 or more than 30 Subject had undergone surgery of the gastro-intestinal tract Subject had donated a unit of blood or participated in another clinical trial, within the last two months before the first treatment. Subject had a history of drug or alcohol abuse. Subject who smokes more than 10 cigarettes per day. Subject had used any prescription medication within 14 days, or any non-prescription medication within 7 days, before the first treatment. Subject had a history of allergic to Statins
Age
From 18 years old to 50 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 24
More than 1 sample in each individual
Number of samples in each individual: 2
Each volunteer, 2 times take medicine in the study. One time test product and the other time reference product with at least one week wash-out period.
Randomization (investigator's opinion)
Randomized
Randomization description
Using Excel software, each subject will be randomly assigned to one of the two sequence AB or BA in a balanced manner.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethicc committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak، 7th Floor, Bldg No.2 SBUMS, Arabi Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-02-21, 1395/12/03
Ethics committee reference number
IR.SBMU.REC.1395.50

Health conditions studied

1

Description of health condition studied
Hyperlipidemia
ICD-10 code
E78.5
ICD-10 code description
Hyperlipidemia, unspecified

Primary outcomes

1

Description
Plasma concentration of Rosuvastatin
Timepoint
At 0 (before dosing), 1.0, 2.0, 3.0, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 24.0 & 48.0 hr. after drug administration
Method of measurement
High Performance Liquid Chromatography (HPLC)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Single dose of 2 tablets of Rosuvastatin 20mg tablet of Tolidarou Pharm Co., IRAN
Category
Other

2

Description
Control group: Single dose of 2 tablets of Crestor 20mg tablet of Astra-Zeneca
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Core Research Lab. of ZAUMS
Full name of responsible person
Gholamreza Komeili
Street address
Emam Ali Hospital, Salamat Blv., Khalij-e-Fars Highway
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5664
Fax
+98 54 3329 5665
Email
crl@zaums.ac.ir
Web page address
http://crl.zaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tolidaru Pharmaceutical Company
Full name of responsible person
Dabir-Syaghi Alireza
Street address
ST Yadegar , Saveh highway
City
Tehran
Province
Tehran
Postal code
1371616314
Phone
+98 21 6117
Fax
+98 21 6662 0175
Email
info@toliddaru.ir
Web page address
http://www.toliddaru.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tolidaru Pharmaceutical 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
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
1st floor, Saeidi Dd end, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
1st floor, Saeidi Dd end, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pars Biopharmacy Research Co.
Full name of responsible person
Ladan Tayebi
Position
Managing Director
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
1st floor, Saeidi Dd end, Felestin Ave.
City
Tehran
Province
Tehran
Postal code
1416673971
Phone
+98 21 8895 6061
Fax
+98 21 8896 9958
Email
l.tayebi@parsbiopharmacy.com
Web page address

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
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