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Bioequivalence study of Pirfenidone capsule 267mg (Pirfenzi) manufactured by Zistdaru Danesh company in healthy volunteers

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History
# Registration date Revision Id
2 2024-07-16, 1403/04/26 311151
1 2021-07-08, 1400/04/17 189485
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  • Protocol summary

    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 24 h periods. 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.
    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 24 h periods. 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 nurse immediately before and after the volunteers take the drug, and the steps for preparing the samples include plasma separation and drug extraction to analyze the amount of drug on them. This study is performed in Radin Laboratory in Tabriz.
    اين مطالعه از نوع یک سویه کور (a single-blinded)، متقاطع (Cross over) و ناشتا (fasting) و روي دو سري از داوطلبين سالم (two sequence) انجام خواهد شد. مطالعه در دو بازه زماني 24ساعته (2period) انجام خواهد شد. فاصله اين دو بازه که اصطلاحا زمان پاکسازي (wash-out) اطلاق مي گردد با توجه به نيمه عمر پلاسمايي دارو تعيين مي گردد که بر اساس منابع علمي اين زمان حداقل بايد بين 5 تا 7 نيمه عمر دارو باشد .داروی مورد مطالعه در اين طرح با در نظر گرفتن اينکه نيمه عمر بيولوژيک داروی موجود در شکل دارویی، زمان پاکسازي دارو یک هفته در نظر گرفته خواهد شد.در دور اول مطالعه داوطلبين در دو گروه تقسيم شده و گروه اول يک قرص نمونه (test) و گروه دوم يک قرص برند دريافت مي نمايند. نمونه هاي خوني بلافاصله قبل و پس از مصرف دارو توسط داوطلبان، توسط پزشک همکار گرفته شده و مراحل آماده سازي نمونه ها شامل جداسازي پلاسما و استخراج دارو جهت آناليز مقدار دارو بر روي آنها انجام مي گردد.
    اين مطالعه از نوع یک سویه کور (a single-blinded)، متقاطع (Cross over) و ناشتا (fasting) و روي دو سري از داوطلبين سالم (two sequence) انجام خواهد شد. مطالعه در دو بازه زماني 24ساعته (2period) انجام خواهد شد. فاصله اين دو بازه که اصطلاحا زمان پاکسازي (wash-out) اطلاق مي گردد با توجه به نيمه عمر پلاسمايي دارو تعيين مي گردد که بر اساس منابع علمي اين زمان حداقل بايد بين 5 تا 7 نيمه عمر دارو باشد .داروی مورد مطالعه در اين طرح با در نظر گرفتن اينکه نيمه عمر بيولوژيک داروی موجود در شکل دارویی، زمان پاکسازي دارو یک هفته در نظر گرفته خواهد شد.در دور اول مطالعه داوطلبين در دو گروه تقسيم شده و گروه اول يک قرص نمونه (test) و گروه دوم يک قرص برند دريافت مي نمايند. نمونه هاي خوني بلافاصله قبل و پس از مصرف دارو توسط داوطلبان، توسط پرستار گرفته شده و مراحل آماده سازي نمونه ها شامل جداسازي پلاسما و استخراج دارو جهت آناليز مقدار دارو بر روي آنها انجام مي گردد. این مطالعه در آزمایشگاه رادین در تبریز انجام میشود.

  • General information

    2021-07-23, 1400/05/01
    2024-10-22, 1403/08/01
    2021-09-21, 1400/06/30
    2025-11-21, 1404/08/30
    empty
    Changing the sampling date and place
    empty
    تغییر زمان و محل نمونه گیری

  • Health conditions studied

    #1
    This study is performed on healthy volunteers.
    این مطالعه در داوطلبین سالم انجام شده است

  • Recruitment centers

    #1
    Name of recruitment center - English: شرکت سیمین بسپار طیف گستر
    Name of recruitment center - Persian: Simin Bespar Teyf Gostar company
    Full name of responsible person - English: Sima Sadrai
    Full name of responsible person - Persian: سیما صدرای
    Street address - English: Zistdaru Danesh Co., Second floor, No.98, Bozorgmehr St., Velsale Shirazi st., Enghelab St.
    Street address - Persian: خیابان انقلاب، خیابان وصال شیرازی، خیابان بزرگمهر، پلاک 98، طبقه دوم، شرکت زیست دارو دانش
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417833714
    Phone: +98 21 6695 5196
    Fax:
    Email: Sadrai@tums.ac.ir
    Web page address:
    Name of recruitment center - English: Radin laboratory
    Name of recruitment center - Persian: آزمایشگاه رادین
    Full name of responsible person - English: SiJavad Shokri
    Full name of responsible person - Persian: جواد شکری
    Street address - English: Radin laboratory, No. 22, first floor, Azadi building, Moalem St., Abureyhan St.
    Street address - Persian: خیابان ابوریحان، خیابان معلم، ساختمان آزادی، طبقه اول، پلاک ۲۲، آزمایشگاه رادین
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5154995671
    Phone: +98 914 313 5843
    Fax:
    Email: Shokri.j@gmail.com
    Web page address:

Protocol summary

Study aim
Bioequivalence Study of Pirfenidone capsule 267mg manufactured by Zistdaru Danesh company (Pirfenzi 267mg) versus originator brand (Esbriet 267mg) 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 24 h periods. 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 nurse immediately before and after the volunteers take the drug, and the steps for preparing the samples include plasma separation and drug extraction to analyze the amount of drug on them. This study is performed in Radin Laboratory in Tabriz.
Participants/Inclusion and 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 Pirfenidone
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 sampling date and place
Acronym
IRCT registration information
IRCT registration number: IRCT20200623047902N3
Registration date: 2021-07-08, 1400/04/17
Registration timing: prospective

Last update: 2024-08-11, 1403/05/21
Update count: 1
Registration date
2021-07-08, 1400/04/17
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
recruiting
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Pirfenidone capsule 267mg (Pirfenzi) manufactured by Zistdaru Danesh company in healthy volunteers
Public title
Bioequivalence study of Pirfenidone 267mg
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (Liver, Heart and Kidney) Body Mass Index (18-28) Informed consent Age (18-60)
Exclusion criteria:
Smoking History of cardiovascular disease History of liver and kidney disease Pregnancy Alcoholism and Narcoticism History of allergy to Pirfenidone
Age
From 18 years old to 60 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: 16
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: Pirfenzi recipient) and the second twelve are considered as (second sequence: Esbriet 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). Pirfenzi and Esbriet 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
Zistdaru Danesh Co., Second floor, No.98, Bozorgmehr St., Velsale Shirazi st., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1417833714
Approval date
2021-07-05, 1400/04/14
Ethics committee reference number
IR.TBZMED.REC.1400.310

Health conditions studied

1

Description of health condition studied
This study is performed on healthy volunteers.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determination of concentration of drug in bood
Timepoint
before, 0.5 h, 45 min, 1h, 80min, 100min, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h , 12h and 24h after drug consumption
Method of measurement
HPLC-MASS MASS

Secondary outcomes

1

Description
Time to reach maximum concentration
Timepoint
0.5h, 45min, 1h, 80min, 100min, 2h, 2.5h, 3h, 3.5h, and 4 h after drug consumption
Method of measurement
Observe drug concentrations at different times

2

Description
Area under curve
Timepoint
After determining the amount of drug
Method of measurement
Calculation

Intervention groups

1

Description
Intervention group: Volunteers take Pirfenzi 267 mg capsule, which is manufactured by Zistdaru Danesh Company and contains 267 mg of Pirfenidone, as a test product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the drug in the blood is determined.
Category
Treatment - Drugs

2

Description
Intervention group: Volunteers take Esbriet capsule, which is manufactured by Roche Company and contains 267 mg of Pirfenidone, as a reference product, as a single oral dose, and at the specified time, they are taken blood and the concentration of the drug in the blood is determined.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Radin laboratory
Full name of responsible person
SiJavad Shokri
Street address
Radin laboratory, No. 22, first floor, Azadi building, Moalem St., Abureyhan St.
City
Tabriz
Province
East Azarbaijan
Postal code
5154995671
Phone
+98 914 313 5843
Email
Shokri.j@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zistdaru Danesh Company
Full name of responsible person
Hooshmand Ilka
Street address
No. 10, 8th floor, Faraz building, Sahand St., Beheshti St.
City
Tehran
Province
Tehran
Postal code
1559836438
Phone
+98 21 4231 8000
Email
ilka@zistdaru.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zistdaru Danesh 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
Zistdaru Danesh company
Full name of responsible person
Elham Ghasemian
Position
Deputy director of research and development
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zistdaru Danesh Co., second floor, No.98, Bozorgmehr St., Vesale Shirazi St., Enghelab St
City
Tehran
Province
Tehran
Postal code
1417833714
Phone
+98 21 6696 5196
Email
ghasemian@zistdaru.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zistdaru Danesh company
Full name of responsible person
Elham Ghasemian
Position
Deputy director of research and development
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zistdaru Danesh Co., Second floor, No.98, Bozorgmehr St., Vesale Shirazi St., Enghelab St
City
Tehran
Province
Tehran
Postal code
1417833714
Phone
+98 21 6696 5196
Email
ghasemian@zistdaru.ir

Person responsible for updating data

Contact
Name of organization / entity
Zistdaru Danesh company
Full name of responsible person
Elham Ghasemian
Position
Deputy director of research and development
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Zistdaru Danesh Co., Second floor, No.98, Bozorgmehr St., Vesale Shirazi St., Enghelab St
City
Tehran
Province
Tehran
Postal code
1417833714
Phone
+98 21 6696 5196
Email
Ghasemian@zistdaru.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
These data are as secure between researcher and related industries.
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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only protocol and methods of study are sharable (analytical method and validation of analytical method)
When the data will become available and for how long
8 months after publication of results
To whom data/document is available
University researchers
Under which criteria data/document could be used
similar study
From where data/document is obtainable
Elham Ghasemian Ghasemian@zistdaru.ir
What processes are involved for a request to access data/document
After evaluation of reasons to apply, it will be sent during 60 working days
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