An open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Aristatin 5 mg tablet of Arya Pharm Co., IRAN and Crestor 5 mg tablet of Astra-Zeneca in 24 healthy adult subjects under fasting condition
Crestor 5 mg tablet of Astra-Zeneca can be changed by Aristatin 5 mg tablet of Arya Pharm Co., IRAN?
Design
An open label, two treatments, two periods, single dose, crossover, bioequivalence study of Aristatin 5 mg tablet of Arya Pharm Co., IRAN in comparison of Crestor 5 mg tablet of Astra-Zeneca in 24 healthy subjects under fasting condition
Settings and conduct
Sampling center: Core Research Lab. of Zahedan University of Medical Sciences
Method of sampling:
1- Subject no. and condition: 24 healthy subjects
2- Dose & administration: A single dose of 2*5 mg rosuvastatin under fasting condition
3-Sampling time: 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. post-dose.
4- Period of treatment phases: two times separate by a washout period of at least 7 days.
5- Method analysis of rosuvastatin in the plasma: HPLC.
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; 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 Aristatin 5 mg tablet of Arya Pharm Co., IRAN Control: single dose of Crestor 5 mg tablet of Astra-Zeneca
Main outcome variables
Plasma concentration of rosuvastatin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190706044111N12
Registration date:2019-11-10, 1398/08/19
Registration timing:prospective
Last update:2019-11-10, 1398/08/19
Update count:1
Registration date
2019-11-10, 1398/08/19
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
2019-11-22, 1398/09/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An open label, two treatments, two periods, two sequence, single dose, crossover, bioequivalence study of Aristatin 5 mg tablet of Arya Pharm Co., IRAN and Crestor 5 mg tablet of Astra-Zeneca in 24 healthy adult subjects under fasting condition
Public title
Bioequivalence study of Aristatin 5 mg tablet of Arya Pharm
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 showed clinically relevant deviations from normal in physical examination.
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 three 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)
Not randomized
Randomization description
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
2018-09-02, 1397/06/11
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.359
Health conditions studied
1
Description of health condition studied
Hyperlipidemia
ICD-10 code
ICD-10 code description
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 dosing
Method of measurement
HPLC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single dose of Aristatin 5 mg tablet of Arya Pharm Co., IRAN
Category
Other
2
Description
Control group: Single dose of Crestor 5 mg tablet of Astra-Zeneca
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Core Research Lab. of Zahedan University of Medical SciencesS
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
Arya Pharm Company
Full name of responsible person
Shabestari Rahim
Street address
Karaj Makhsous Highway, daroupakhsh Ave.
City
Tehran
Province
Tehran
Postal code
۱۳۹۷۱۳۳۱۱۱
Phone
+98 21 4498 1081
Fax
+98 21 4498 9243
Email
info@aryapharm.com
Web page address
http://aryapharm.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arya Pharm 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
Web page address
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