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Comparative bioequivalence study of the Regorafenib 40 mg, tablet manufactured by Noavaran Daroui Kimia Company

Protocol summary

Study aim
Examining the bioequivalency of domestically produced Regorafenib tablet formulations with brand samples(Stivarga®)
Design
A single-group, not blinded, not randomized, bioequivalence clinical trial on 24 healthy volunteers.
Settings and conduct
Study place: Drug Applied Research Center affiliated to Tabriz University of Medical Science. The number of 24 volunteer in the age range of 18-60 years and the Body Mass Index range of 18-30, who are voluntarily selected through public notification. One tablet is taken fasting and blood is taken at 17 times point. Three week later, the process is repeated for the brand medicine
Participants/Inclusion and exclusion criteria
The weight range of participating candidates should be between 60-100 kg All candidates must be non-smokers Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (γ-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose Volunteers who have agreed to an informed consent form
Intervention groups
After taking a Regorafenib 40-mg tablet from domestic company, 3 milliliters of blood will be collected from the volunteer in 17 times intervals for 96 hours. Three week later, the process is repeated for a brand sample tablet. The drug concentration is measured in plasma
Main outcome variables
Studying the Drug pharmacokinetic parameters including measuring the plasma concentrations for brand and test products, determining the desired and important pharmacokinetic parameters in bioequivalence studies, AUCs, Tmax, Cmax, T1/2 and appropriate statistical analysis of the data

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130313012810N24
Registration date: 2024-01-22, 1402/11/02
Registration timing: prospective

Last update: 2024-01-22, 1402/11/02
Update count: 0
Registration date
2024-01-22, 1402/11/02
Registrant information
Name
Hamed Hamishehkar
Name of organization / entity
Drug Applied Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1336 3311
Email address
hamishehkar.hamed@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-25, 1402/11/05
Expected recruitment end date
2024-01-26, 1402/11/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of the Regorafenib 40 mg, tablet manufactured by Noavaran Daroui Kimia Company
Public title
Regorafenib tablet bioequivalence
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The weight range of participating candidates should be between 60-100 kg All candidates must be non-smokers Candidates should be healthy in terms of physical examination, ECG and the following laboratory tests: Hemoglobin, Hematocrit, Red and White Blood Count, MCV (Mean Body Volume), MCH (Mean Body Hemoglobin), Routine Urinalysis, Total Cholesterol, Triglyceride, Total Proteins, albumin, uric acid, total bilirubin, alkaline phosphatase, gamma glutamyl transpeptidase (γ-GT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), urea, creatinine and fasting blood glucose. Volunteers who have agreed to an informed consent form. All candidates should not consume caffeine-containing drinks and chocolate during two days before the prescription, and this restriction must be followed until the last blood draw
Exclusion criteria:
History of allergic or adverse reaction to Pazopanib or any similar product Volunteers with blood pressure less than 60/90 mm Hg or higher than 90/140 mm Hg Smokers Individuals who donated whole blood or blood components within 2 months within 2 weeks prior to the first dose of the study product(s) Due to the possibility of QT prolongation complications, volunteers with a family history of heart diseases, especially rhythm disorders, are excluded from the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
N/A
Randomization description
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 Sciences
Street address
Drug Applied Research Center, Daneshghah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2024-01-14, 1402/10/24
Ethics committee reference number
IR.TBZMED.REC.1402.775

Health conditions studied

1

Description of health condition studied
Bioequivalence study in healthy volunteers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plasma concentration of the drug
Timepoint
17 sampling time till 96 h
Method of measurement
Liquid Chromatography with tandem mass spectrometry (LC-MS-MS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This study examines the bioequivalence of the Regorafenib tablet produced by a domestic company with a foreign brand sample. We have only one intervention group and there is no control group. The intervention group, which includes healthy, fasting volunteers, will receive a single dose, 40 mg tablet manufactured by the pharmaceutical company Noavaran Daroui Kimia and Stivarga® brand, in two 96-hour periods with an interval of three week, on the day of the study. And in 17 different time periods up to 96 hours after taking the medicine, blood samples will be taken from the volunteers in the amount of 3 ml each time, that is, a total of 51 ml within 96hours. The training that will be given to the volunteers includes avoiding the consumption of drinks containing alcohol and xanthine and other interfering drugs in the prescription drug from 48 hours before the start of the study until the end of the study.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Drug Applied Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Hamed Hamishehkar
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences,Daneshghah St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kimia Noavaran Daroui
Full name of responsible person
Esmaeil Moazeni
Street address
No. 1462, Jalal-Al-Ahmad Highway, Karghar Shomali
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 2946
Email
info@kimia-pharma.co
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kimia Noavaran Daroui
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
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences, Daneshghah St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/

Person responsible for scientific 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
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences, Daneshghah St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/

Person responsible for updating data

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
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences, Daneshghah St., Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
51656-65811
Phone
+98 41 3336 3181
Fax
+98 41 3336 3311
Email
hamishehkar.hamed@gmail.com
Web page address
http://darc.tbzmed.ac.ir/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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