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Comparative bioequivalence study of the Amlodipine 5-mg/Valsartan 160-mg tablet manufactured by Behestan Pharmaceutical Company versus Exforege® (Novartis).

Protocol summary

Study aim
Demonstration of bioequivalence of Amlodipine 5-mg/Valsartan 160-mg tablet of Behestan Pharmaceutical Company with Exforege® tablet manufactured by Novartis after single dose administration.
Design
Single dose, randomized and crossover bioequivalence study of Amlodipine 5-mg/Valsartan 160-mg tablet by Behestan Co. with Exforege® (Novartis) in 24 healthy male volunteers in two groups under fasting condition.
Settings and conduct
Study place and the place for Blood sample analysis are the Drug Applied Research Center affiliated to Tabriz University of Medical Science, respectively. 24 healthy male volunteers will receive each of test or reference Amlodipine/Valsartan tablet in random sequence according to the randomization schedule. The interval between receiving the medicine (washout period) is 14 days, If the first sequence receives Iranian medicine, they will receive brand medicine. Blood samples will be taken from all participants before and after receiving the drug at 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 and 96 hours after dosing.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Healthy male subjects in the age range of 18-50 years and BMI (Body Mass Index) of 19-30. Exclusion criteria: Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function or a history of TB, epilepsy, asthma, DM, psychosis or glaucoma and regular smoker.
Intervention groups
Intervention group 1: Amlodipine 5-mg/Valsartan 160-mg tablet by Behestan Co. is the test product. Intervention group 2: Exforege® (Novartis) is the reference product. In each period, 12 of 24 subjects will be given single dose of this product. After the washout period, the volunteers are placed in the opposite group.
Main outcome variables
Peak Plasma Concentration (Cmax); Area under the concentration-time curve (AUC).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200407046981N29
Registration date: 2022-05-09, 1401/02/19
Registration timing: prospective

Last update: 2022-05-09, 1401/02/19
Update count: 0
Registration date
2022-05-09, 1401/02/19
Registrant information
Name
Fatima Molavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 2700
Email address
molavif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-22, 1401/05/31
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of the Amlodipine 5-mg/Valsartan 160-mg tablet manufactured by Behestan Pharmaceutical Company versus Exforege® (Novartis).
Public title
Study of absorption and elimination rate of Amlodipine 5-mg/Valsartan 160-mg tablet in comparison with Amlodipine/Valsartan brand tablet (Exforege®).
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The weight limit of each volunteer should be between 60 and 100 kg. All volunteers must be non-smokers. They must be healthy in terms of liver, kidney, respiratory system, mental and other general health characteristics that will be assessed. Candidates who have consented to the consent form.
Exclusion criteria:
Known hypersensitivity or idiosyncratic reaction to Amlodipine/Valsartan or any ingredients. Subjects with BP ≤ 90/60 mm/Hg or BP ≥ 140/90 mm/Hg. Regular smoker who smokes more than ten cigarettes daily. Taking any medicine during two weeks before dosing.
Age
From 18 years old to 50 years old
Gender
Male
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
In each period, 12 of 24 subjects will be given single dose of this product (Domestic or brand). After the washout period, the volunteers are placed in the opposite group.
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign people in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope after entering the study, and numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of the both groups will change for the second period.
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 Tabriz University of Medical Science
Street address
Third floor, central building No. 2, Golgasht street, Tabriz University of Medical Science, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-04-19, 1401/01/30
Ethics committee reference number
IR.TBZMED.REC.1401.125

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Peak Plasma Concentration (Cmax)
Timepoint
At 0 before dosing 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 and 96 hours after dosing
Method of measurement
High-performance liquid chromatography—mass spectrometry (HPLC-MS)

Secondary outcomes

1

Description
AUC (Area Under the Concentration-Time Curve)
Timepoint
At 0 before dosing 1, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 and 96 hours after dosing
Method of measurement
Using non-compartmental model of Win-Nonlin Professional software version 3.2.A (Pharsight Corporation, USA) or SPSS

Intervention groups

1

Description
Intervention group 1: In this group, volunteers are given a single oral dose of Amlodipine 5-mg/Valsartan 160-mg tablet produced by Behestan Co. (Domestic). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 2.
Category
Treatment - Drugs

2

Description
Intervention group 2: In this group, volunteers are given a single oral dose of Amlodipine 5-mg/Valsartan 160-mg tablet (Exforege®), produced by Novartis Company (Brand). In each period, 12 of 24 subjects will be given single oral dose of this product. After the washout period, the volunteers are placed in the Intervention group 1.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Drug Applied Research Center
Full name of responsible person
Hamed Hamishehkar
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Fax
+98 41 3336 7914
Email
hamishehkar.hamed@gmail.com
Web page address
https://darc.tbzmed.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Behestan Pharmaceutical Company
Full name of responsible person
Mahdi Orouji
Street address
Behestan bldg., #10 Pardis st., Mollasadra Ave. Tehran 1991915613, Iran
City
Tehran
Province
Tehran
Postal code
141554318
Phone
+98 21 8877 4200
Email
info@behestandarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Behestan 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
Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaeutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Email
Hamishehkar.hamed@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jaber Emami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Hezarjarib St., School of Pharmacy and Pharmaceutical Sciences , Isfahan, Iran
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7111
Fax
+98 31 3668 0011
Email
Emami@pharm.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fatima Molavi
Position
Non-Faculty Academic Position
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutics
Street address
Drug Applied Research Center, In front of Shahid Madani Hospital, Daneshghah Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3336 7914
Email
F.molavi85@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
There is no further information
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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not 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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