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General information
empty
Changing the name of sampling center
Changing the name of sampling center
empty
تغییر نام محل نمونه گیری
تغییر نام محل نمونه گیری
Recruitment centers
#1
Name of recruitment center - English: Simin Baspar Teyf Gostar Company
Name of recruitment center - Persian: شرکت سیمین بسپار طیف گستر
Full name of responsible person - English: Javad Shokri
Full name of responsible person - Persian: جواد شکری
Street address - English: No.48,Ferdos Street
Street address - Persian: خیابان فردوس، پلاک 48
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5167874434
Phone: +98 41 3384 2724
Fax:
Email: Shokri.j@gmail.com
Web page address:
Name of recruitment center - English: Dr. Shokri Laboratory
Name of recruitment center - Persian: آزمایشگاه دکتر شکری
Full name of responsible person - English: Javad Shokri
Full name of responsible person - Persian: جواد شکری
Street address - English: No.48,Ferdos Street
Street address - Persian: خیابان فردوس، پلاک 48
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5167874434
Phone: +98 41 3384 2724
Fax:
Email: Shokri.j@gmail.com
Web page address:
Name of recruitment center - English: Simin Baspar Teyf Gostar CompanyDr. Shokri Laboratory Name of recruitment center - Persian: شرکت سیمین بسپار طیف گسترآزمایشگاه دکتر شکری Full name of responsible person - English: Javad Shokri Full name of responsible person - Persian: جواد شکری Street address - English: No.48,Ferdos Street Street address - Persian: خیابان فردوس، پلاک 48 City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5167874434 Phone: +98 41 3384 2724 Fax: Email: Shokri.j@gmail.com Web page address:
Protocol summary
Study aim
Bioequivalence Study of ٰValsartan tablet 160mg manufactured by Sanamed company versus originator brand (Diovan 160mg) manufactured by Roche company
Design
Bioequivalence study, crossover, a blind, 24 healthy volunteers. Simple randomization was used for randomization
Settings and conduct
The study will be conducted in a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be conducted in two periods (48h). 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 at this time should be at least 5 to 7 half-life of the drug. Given that the biological half-life of the drug is in drug form, the time to clear the drug will be one week. Blood samples are taken by the doctor immediately before and after the drug is taken by the volunteers, and the steps for preparing the samples include plasma separation and drug extraction to analyze the amount of drug on them.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: General Health (Liver, Heart, and Kidney), Body Mass Index (18-28), Informed consent, Age (18-45 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Pregnancy, Alcoholism and Narcoticism, History of allergy to ٰValsartan
Intervention groups
In this study, two groups of intervention and control are not applicable. Both groups will receive test-reference medicine and testing on two different occasions, and therefore the test results will be independent of individual differences and will only indicate differences in the formulation of the two drugs.
Main outcome variables
Maximum drug concentration, Time to reach to maximum drug concentration, Half life of drug
General information
Reason for update
Changing the name of sampling center
Acronym
IRCT registration information
IRCT registration number:IRCT20200623047902N5
Registration date:2021-07-11, 1400/04/20
Registration timing:prospective
Last update:2024-07-20, 1403/04/30
Update count:1
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
Elham Ghasemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 5196
Email address
ghasemian@zistdaru.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-05, 1400/05/14
Expected recruitment end date
2021-10-07, 1400/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Valsartan 160mg manufactured by Sanamed company in healthy volunteers
Public title
Bioequivalence study of Valsartan 160 mg
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart and Kidney)
Body Mass Index (18-28)
Informed consent
Age (18-60 years old)
Exclusion criteria:
Smoking
History of cardiovascular disease
History of liver and kidney disease
Pregnancy
Alcoholism and Narcoticism
History of allergy to Valsartan
Age
From 18 years old to 45 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
17
blood sample
Randomization (investigator's opinion)
Randomized
Randomization description
People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball and poured into a container and mixed. The balls are then removed randomly from the container. The first twelve are considered as (first sequence: Valsartan 160mg manufactured by Sanamed recipient) and the second twelve are considered as (second sequence: Diovan 160mg recipient). The volunteers don't have any information about taking the test drug or brand drug
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). Valsartan (manufactured by Sanamed) and Diovan 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
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
No. 1, second floor, Hekmat Alley, Between Vesal and Palestine St., Bozorgmehr St., Valiasr St
City
Tehran
Province
Tehran
Postal code
1416844983
Approval date
2021-07-05, 1400/04/14
Ethics committee reference number
IR.TBZMED.REC.1400.308
Health conditions studied
1
Description of health condition studied
Healthy volunteers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
Hour
Method of measurement
blood sampling
Secondary outcomes
1
Description
Pharmacokinetic parameters
Timepoint
After intervention
Method of measurement
Theoretical and pahrmacokinetic equations
Intervention groups
1
Description
Intervention group: single dose, Diovan 160 mg tablet, Novartis, as reference product
Category
Treatment - Drugs
2
Description
Intervention group: Single dose, Valsartan 160mg, Sanamed company, as test product
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Shokri Laboratory
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
Sanamed pharma company
Full name of responsible person
Farshid Malek Marzban
Street address
No.1, Second floor, Hekmat alley, between Palestine and Vesal St., Bozorgmehr st., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1416844983
Phone
+98 21 6640 3568
Email
info@sanamedpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanamed pharma 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
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visitingprofessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.1, Second floor, Hekmat alley, between Palestine and Vesal St., Bozorgmehr st., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1416844983
Phone
+98 21 6640 3568
Email
Ghasemian_elham@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visitingprofessor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.1, Second floor, Hekmat alley, between Palestine and Vesal St., Bozorgmehr st., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1416844983
Phone
+98 21 6640 3568
Email
Ghasemian_elham@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elham Ghasemian
Position
Visiting professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.1, Second floor, Hekmat alley, between Palestine and Vesal St., Bozorgmehr st., Valiasr St.
City
Tehran
Province
Tehran
Postal code
1416844983
Phone
+98 21 6640 3568
Email
ghasemian_elham@yahoo.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 data are as secure between researcher and related industries.