History
# Registration date Revision Id
2 2025-04-23, 1404/02/03 339217
1 2025-01-05, 1403/10/16 326120
Changes made to previous revision
  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents
  • Protocol summary

    Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in Iron deficiency anemic patients in the fasted condition
    Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in healthy volunteers in the fasted condition
    هم ارزی زیستی محلول تزریقی فریک کربوکسی مالتوز ۵۰ میلی گرم در میلی لیتر شرکت زیست دارو دانش (فریرایز) در قیاس با برند اصلی (فراینجکت) در بیماران آنمیک فقر آهن در حالت ناشتا
    هم ارزی زیستی محلول تزریقی فریک کربوکسی مالتوز ۵۰ میلی گرم در میلی لیتر شرکت زیست دارو دانش (فریرایز) در قیاس با برند اصلی (فراینجکت) در داوطلبین سالم در حالت ناشتا
    Bioequivalence study with 2 intervention groups, Parallel, single-blinded, Two groups of 25 people of iron deficiency anemic patients. The rand function of Excel software was used for randomization.
    Bioequivalence study with 2 intervention groups, Parallel, single-blinded, Two groups of 25 healthy volunteers. The rand function of Excel software was used for randomization.
    مطالعه هم ارزی زیستی دارای 2 گروه مداخله، گروههای موازی، یکسویه کور، تصادفی شده، بر دو گروه ۲۵ نفره از بیماران آنمیک فقر آهن. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
    مطالعه هم ارزی زیستی دارای 2 گروه مداخله، گروههای موازی، یکسویه کور، تصادفی شده، بر دو گروه ۲۵ نفره از داوطلبین سالم. برای تصادفی سازی از فانکشن rand نرم افزار اکسل استفاده شد.
    The study is single-blinded, parallel, fasted, and on two series of anemic patients. The study will be done in one period (72h). The candidates are divided into two groups. the first group receives a test product and the second group receives a brand product. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin Laboratory in Tabriz.
    The study is single-blinded, parallel, fasted, and on two series of healthy volunteers. The study will be done in one period (72h). The candidates are divided into two groups. the first group receives a test product and the second group receives a brand product. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin Laboratory in Tabriz.
    اين مطالعه از نوع یک سویه کور، موازی و ناشتا و روی دو سری از بیماران آنمیک است. مطالعه در یک بازه زمانی ۷۲ ساعته انجام خواهد شد. داوطلبين در دو گروه تقسيم شده و گروه اول محصول نمونه و گروه دوم محصول برند دريافت می نمايند. نمونه های خونی بلافاصله قبل و پس از مصرف دارو توسط داوطلبان، گرفته شده و مراحل آماده سازی نمونه ها و استخراج دارو جهت آناليز مقدار دارو بر روی آنها انجام می گردد. این مراحل در شرکت تجزیه و سنجش رادین شیمی در تبریز انجام میگیرد.
    اين مطالعه از نوع یک سویه کور، موازی و ناشتا و روی دو سری از داوطلبین سالم است. مطالعه در یک بازه زمانی ۷۲ ساعته انجام خواهد شد. داوطلبين در دو گروه تقسيم شده و گروه اول محصول نمونه و گروه دوم محصول برند دريافت می نمايند. نمونه های خونی بلافاصله قبل و پس از مصرف دارو توسط داوطلبان، گرفته شده و مراحل آماده سازی نمونه ها و استخراج دارو جهت آناليز مقدار دارو بر روی آنها انجام می گردد. این مراحل در شرکت تجزیه و سنجش رادین شیمی در تبریز انجام میگیرد.
    Inclusion Criteria: Weight over 50 kg, Adult patients with the problem of iron deficiency anemia for which oral iron supplements alone are not sufficient for treatment or are not suitable for them, Ferric carboxymaltose drug is prescribed for them, Informed consent, Age (18-55 years old) Exclusion criteria: Pregnancy and breastfeeding, History of allergy to ferric carboxy maltose or similar drugs, Patients with high blood pressure, Blood loss in a way that leads to hemodynamic instability, receiving intravenous iron in the last 3-6 months.
    Inclusion Criteria: Weight over 50 kg, Informed consent, Age (18-55 years old) Exclusion criteria: Pregnancy and breastfeeding, History of allergy to ferric carboxy maltose or similar drugs, Patients with high blood pressure, Blood loss in a way that leads to hemodynamic instability, receiving intravenous iron in the last 3-6 months.
    معیار ورود: وزن بالای ۵۰ کیلوگرم،بیماران بالغ با مشکل آنمی فقر آهن که مکمل های آهن خوراکی به تنهایی برای درمان کافی نیست و یا برای آنها مناسب نیست، داروی فریک کربوکسی مالتوز برای آنها تجویز شده، رضایت آگاهانه، سن(18-55سال) شرایط عمده عدم ورود: بارداری و شیردهی، سابقه حساسیت به فریک کربوکسی مالتوز یا داروهای مشابه، بیماران با فشار خون بالا، از دست دادن خون به صورتی که منجر به hemodynamic instability شود.دریافت آهن تزریقی طی ۳-۶ ماه گذشته.
    معیار ورود: وزن بالای ۵۰ کیلوگرم، رضایت آگاهانه، سن(18-55سال) شرایط عمده عدم ورود: بارداری و شیردهی، سابقه حساسیت به فریک کربوکسی مالتوز یا داروهای مشابه، بیماران با فشار خون بالا، از دست دادن خون به صورتی که منجر به hemodynamic instability شود.دریافت آهن تزریقی طی ۳-۶ ماه گذشته.
  • General information

    empty
    The FDA proposed protocol update at the end of 2024 for this study, which would allow for the study to be conducted in healthy volunteers at a low dose.
    empty
    به روز رسانی پروتوکل پیشنهادی FDA در انتهای سال ۲۰۲۴برای انجام این مطالعه که امکان انجام مطالعه در داوطلب سالم با دوز کم را فراهم کرده است.
    Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in Iron deficiency anemic patients in the fasted condition
    Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in healthy volunteers in the fasted condition
    هم ارزی زیستی محلول تزریقی فریک کربوکسی مالتوز ۵۰ میلی گرم در میلی لیتر شرکت زیست دارو دانش (فریرایز) در قیاس با برند اصلی (فراینجکت) در بیماران آنمیک فقر آهن در حالت ناشتا
    هم ارزی زیستی محلول تزریقی فریک کربوکسی مالتوز ۵۰ میلی گرم در میلی لیتر شرکت زیست دارو دانش (فریرایز) در قیاس با برند اصلی (فراینجکت) در داوطلبین سالم در حالت ناشتا
    Weight over 50 kg
    Adult patients with the problem of iron deficiency anemia for which oral iron supplements alone are not sufficient for treatment or are not suitable for them
    Ferric carboxymaltose drug is prescribed for them
    Informed consent
    Age (18-55 years old)
    Weight over 50 kg
    Informed consent
    Age (18-55 years old)
    وزن بالای ۵۰ کیلوگرم
    بیماران بالغ با مشکل آنمی فقر آهن که مکمل های آهن خوراکی به تنهایی برای درمان کافی نیست و یا برای آنها مناسب نیست
    داروی فریک کربوکسی مالتوز برای آنها تجویز شده
    رضایت آگاهانه
    سن(18-55سال)
    وزن بالای ۵۰ کیلوگرم
    رضایت آگاهانه
    سن(18-55سال)
  • Health conditions studied

    #1
    D50.8
    Other iron deficiency anemias
    Anemic patients with Iron deficiency
    This study is conducted on healthy volunteers.
    بیماران آنمیک با فقر آهن
    این مطالعه بر داوطلب سالم انجام میشود.
  • Recruitment centers

    #1
    Name of recruitment center - English: Radin Laboratory
    Name of recruitment center - Persian: آزمایشگاه رادین
    Full name of responsible person - English: Javad Shokri
    Full name of responsible person - Persian: جواد شکری
    Street address - English: No.22, first floor, Moalem st., Abureihan St
    Street address - Persian: خيابان ابوريحان، کوي معلم، پلاک 22 ، طبقه اول.
    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:
    Name of recruitment center - English: Radin Laboratory
    Name of recruitment center - Persian: آزمایشگاه رادین
    Full name of responsible person - English: Javad Shokri
    Full name of responsible person - Persian: جواد شکری
    Street address - English: No.22, first floor, Moalem st., Abureihan St
    Street address - Persian: خيابان ابوريحان، کوی معلم، پلاک 22 ، طبقه اول
    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:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Zistdaru danesh Co.
    Name of organization / entity - Persian: شرکت زیست دارو دانش
    Full name of responsible person - English: Hooshmand Ilka
    Full name of responsible person - Persian: هوشمند ایلکا
    Street address - English: No. 404, 4th floor, Rose mall complex, Kharazi highway
    Street address - Persian: اتوبان خرازی، مجتمع رزمال، طبقه 4، پلاک 404
    City - English: تهران
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1498711347
    Phone: +98 21 4231 8100
    Fax:
    Email: ilka@Zistdaru.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Zistdaru danesh Co.
    Name of organization / entity - Persian: شرکت زیست دارو دانش
    Full name of responsible person - English: Hooshmand Ilka
    Full name of responsible person - Persian: هوشمند ایلکا
    Street address - English: No. 404, 4th floor, Rose mall complex, Kharazi highway
    Street address - Persian: اتوبان خرازی، مجتمع رزمال، طبقه 4، پلاک 404
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1498711347
    Phone: +98 21 4231 8100
    Fax:
    Email: ilka@Zistdaru.com
    Web page address:

Protocol summary

Study aim
Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in healthy volunteers in the fasted condition
Design
Bioequivalence study with 2 intervention groups, Parallel, single-blinded, Two groups of 25 healthy volunteers. The rand function of Excel software was used for randomization.
Settings and conduct
The study is single-blinded, parallel, fasted, and on two series of healthy volunteers. The study will be done in one period (72h). The candidates are divided into two groups. the first group receives a test product and the second group receives a brand product. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. These steps are performed in Radin Laboratory in Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Weight over 50 kg, Informed consent, Age (18-55 years old) Exclusion criteria: Pregnancy and breastfeeding, History of allergy to ferric carboxy maltose or similar drugs, Patients with high blood pressure, Blood loss in a way that leads to hemodynamic instability, receiving intravenous iron in the last 3-6 months.
Intervention groups
Intervention group 1: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Vifor Pharma company as a reference Intervention group 2: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Zistdaru Danesh company as a test.
Main outcome variables
Maximum drug concentration, Time to reach maximum concentration, Half-life of drug

General information

Reason for update
The FDA proposed protocol update at the end of 2024 for this study, which would allow for the study to be conducted in healthy volunteers at a low dose.
Acronym
IRCT registration information
IRCT registration number: IRCT20200105046010N127
Registration date: 2025-01-05, 1403/10/16
Registration timing: registered_while_recruiting

Last update: 2025-05-09, 1404/02/19
Update count: 1
Registration date
2025-01-05, 1403/10/16
Registrant information
Name
Javad Shokri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3661 4125
Email address
shokri.j@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of the intravenous solution of Ferric carboxy maltose 50mg/ml (Ferririse)manufactured by Zistdaru Danesh versus originator brand (Ferinject) in healthy volunteers in the fasted condition
Public title
Bioequivalence study of the intravenous solution of Ferric carboxy maltose
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Weight over 50 kg Informed consent Age (18-55 years old)
Exclusion criteria:
Pregnancy and breastfeeding History of allergy to ferric carboxy maltose or similar drugs Patients with high blood pressure Blood loss in a way that leads to hemodynamic instability. Receiving intravenous iron in the last 3-6 months.
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 12
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 eligible candidates are identified. Each candidate is assigned a number from 1 to 50. The rand function of Excel software was used for randomization. The first 25 no.s are considered as (first sequence: Zistdaru Danesh's medicine ) and the second 25 no.s (second sequence: originator brand recipient). The volunteers don't have any information about taking the test or brand drug.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded clinical trial (volunteers). The label of Zistdaru Danesh and the original brand are removed from the vials by the executor and the coded label is installed on it. Candidates don't know about receiving the type of brand medicine or test.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street,
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2024-12-02, 1403/09/12
Ethics committee reference number
IR.TBZMED.REC.1403.780

Health conditions studied

1

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

Primary outcomes

1

Description
Plasma concentration of the drug
Timepoint
Before, 0.5, 0.45, 1, 2, 4, 6, 12, 24, 36, 48 and 72h after drug administration
Method of measurement
Liquid Chromatography Mass-Mass

Secondary outcomes

1

Description
Time to reach maximum plasma concentration
Timepoint
After intervention
Method of measurement
Time to reach the maximum drug concentration in plasma is recorded.

2

Description
Extent of absorption
Timepoint
After intervention
Method of measurement
Calculation of area under curve of concentration -time

Intervention groups

1

Description
Intervention group 1: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Vifor Pharma company as a reference
Category
Treatment - Drugs

2

Description
Intervention group 2: injection solution of ferric carboxy maltose 50 mg/ml manufactured by Zistdaru Danesh company as a test.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Radin Laboratory
Full name of responsible person
Javad Shokri
Street address
No.22, first floor, Moalem st., Abureihan St
City
Tabriz
Province
East Azarbaijan
Postal code
5154995671
Phone
+98 914 313 5843
Fax
Email
shokri.j@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zistdaru danesh Co.
Full name of responsible person
Hooshmand Ilka
Street address
No. 404, 4th floor, Rose mall complex, Kharazi highway
City
Tehran
Province
Tehran
Postal code
1498711347
Phone
+98 21 4231 8100
Email
ilka@Zistdaru.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zistdaru danesh 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
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, 10th Ave., Boostan Street, Roshdieh
City
Tabriz
Province
East Azarbaijan
Postal code
5155935357
Phone
+98 41 3661 4125
Fax
Email
shokri.j@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, 10th Ave., Boostan Street, Roshdieh
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
shokri.j@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 4, 10th Ave., Boostan Street, Roshdieh
City
Tabriz
Province
East Azarbaijan
Postal code
5155935357
Phone
+98 41 3661 4125
Fax
Email
shokri.j@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
These data are as secure between researchers 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
No - There is not a plan to make this available
Loading...