This study was performed to compare the pharmacokinetics and endotracheal parameters of the formulation of Valsartan 160 mg tablet of Karen Company as a test product with the formulation of Diovan® 160 mg tablet of Novartis as a reference product and evaluation of biological equivalence of these two formulations is done.
Design
Randomized, single-dose, crossover comparative bioequivalence study of Valsartan 160 mg of Karen Pharma and Food Supplement Co. and Novartis in 24 healthy male under fasting.
Settings and conduct
In each period, volunteers will receive a single dose of the treatment in the Farabi Clinic (Eslamshahr, Tehran). 2 dosing periods will be separated by a 7-day washout period.
Participants/Inclusion and exclusion criteria
Healthy candidates should be between 18-40 years old and their BMI should be in the range (Kg/m2) 18.5-30.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
History of known allergies to valsartan, new drugs or any of the inactive components of the formulation.
A history of liver or gastrointestinal disease that may interfere with the absorption, distribution, metabolism, or excretion of the drug.
History of liver or kidney disease.
Intervention groups
Intervention group (test): Valsartan 160 mg Tablet, produced by Karen Pharma and Food Supplement Co. is the test product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Intervention group (Reference): Valsartan 160 mg tablet, produced by Novartis is the reference product. In each period, 12 of 24 subjects will be given a single oral dose of this product.
Main outcome variables
Peak Plasma Concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180620040164N18
Registration date:2022-01-08, 1400/10/18
Registration timing:prospective
Last update:2022-01-08, 1400/10/18
Update count:0
Registration date
2022-01-08, 1400/10/18
Registrant information
Name
Behzad Montaha Sangari
Name of organization / entity
Noor research and educational institute (Tavan)
Country
Iran (Islamic Republic of)
Phone
+98 21 6600 7026
Email address
info@tavaninstitute.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-20, 1400/10/30
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of Valsartan 160 mg tablet of Karen Pharma and Food Supplement Co. and Novartis pharmaceuticals.
Public title
Bioequivalence study of Valsartan 160 mg tablet in 24 healthy male under fasting conditions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy candidates should be between 18-40 years old and their BMI should be in the range (Kg/m2) 18.5-30.
Subjects with no significant diseases or clinically significant abnormal findings during screening, medical history, clinical examination and laboratory evaluations.
Subjects must have normal vital signs. Sitting systolic blood pressure is in the range of 110-120 mm Hg and diastolic blood pressure is in the range of 70-80 mm Hg and heart rate is 60-90 beats per minute.
Subjects who agree with patient consent form.
Exclusion criteria:
History of known allergies to valsartan, new drugs or any of the inactive components of the formulation;
A history of liver or gastrointestinal disease that may interfere with the absorption, distribution, metabolism, or excretion of the drug;
History of liver or kidney disease
Smokers who smoke more than 10 cigarettes a day and have trouble not smoking during each clinical study period.
History of anaphylaxis or angioedema
History of bleeding or coagulation problems
People who have taken over-the-counter or prescription drugs 7 days before the start of the first period will need to take the drug at the same time during the study.
People with a history of alcohol or drug addiction
Subjects who consume heavy caffeinated beverages, fruit juices (grapefruit juice) either follow a special diet (vegetarian) or do strenuous physical activity.
History of difficulty donating blood or donating more than 500 ml of blood in less than seven days before the start of the study.
Age
From 18 years old to 45 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization schedule will be generated with the BEAR statistical software (Release V2.7.7). Each volunteer will be randomly assigned to one of the 2 different sequence of treatments according to the order of entering the study which will be allocated after screening.
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
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835113
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
1399.203.IR.SBMU.PHARMACY.REC.
Health conditions studied
1
Description of health condition studied
Bioequivalence investigation of the generic Karen Pharma and Food Supplement Co. Valsartan 160 mg tablet with brand Diovan® 160 mg tablet Novartis pharmaceuticals..
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Peak Plasma Concentration (Cmax)
Timepoint
During 2 months after intervention
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Secondary outcomes
1
Description
AUC (Area Under the Concentration-Time Curve)
Timepoint
During 2 months after intervention
Method of measurement
using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA)
Intervention groups
1
Description
Intervention group: (test): Valsartan 160 mg Tablet, produced by Karen Pharma and Food Supplement Co. is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
2
Description
Intervention group: (reference):Diovan® 160 mg Tablet, produced by Novartis pharmaceuticals is the test product. In each period, 12 of 24 subjects will be given single oral dose of this product.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim Farabi Clinic
Full name of responsible person
Ebrahim Siahpoosh
Street address
No. 57, Shemshad alley, Sallor city
City
Tehran
Province
Tehran
Postal code
4635314588
Phone
+98 21 9253 5647
Email
mina.hasanabadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karen Pharma and Food Supplement Co.
Full name of responsible person
Ali Mazidi
Street address
No: 3, Western Nahid st. Africa Blvd.
City
Tehran
Province
Tehran
Postal code
۱۴۵۹۹۶۵۲۰۴
Phone
+98 21 2620 4283
Email
info@karenpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Karen Pharma and Food Supplement 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
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Noor Research & Development Institute
Full name of responsible person
Ali Aghaei
Position
Master
Latest degree
Master
Other areas of specialty/work
Pharmacy
Street address
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Seyed Mohsen Foroutan
Position
Principal investigator
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht
City
Tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir
Person responsible for updating data
Contact
Name of organization / entity
Tavan Institute
Full name of responsible person
Ali Aghaei
Position
Master
Latest degree
Master
Other areas of specialty/work
pharmacy
Street address
Sharif innovation station, North Habibollah, Hosseini Squ., Teymoury St., Tarasht.
City
tehran
Province
Tehran
Postal code
1459926609
Phone
+98 21 6600 4027
Email
info@tavaninstitute.ir
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
It's not specified yet.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available