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Comparative bioequivalence study of the Naproxen 250 mg, tablet manufactured by Daana Pharma Company

Protocol summary

Study aim
Examining the bioequivalency of domestically produced Naproxen tablet formulations with brand samples(Teva)
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. One 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 Naproxen 250-mg tablet from domestic company, 3 milliliters of blood will be collected from the volunteer in 17 times intervals for 72 hours. One 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

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130313012810N27
Registration date: 2024-04-18, 1403/01/30
Registration timing: prospective

Last update: 2024-04-18, 1403/01/30
Update count: 0
Registration date
2024-04-18, 1403/01/30
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
2024-05-09, 1403/02/20
Expected recruitment end date
2024-05-14, 1403/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of the Naproxen 250 mg, tablet manufactured by Daana Pharma Company
Public title
Naproxen 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 Naproxen 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)
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
Daneshghah St. Drug Applied Research Center
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2024-03-04, 1402/12/14
Ethics committee reference number
IR.TBZMED.REC.1402.994

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 included pre-dose (time 0) and at the following hours post-dose: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 48, and 72 h
Method of measurement
Liquid Chromatography with tandem mass spectrometry (LC-MS-MS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Intervention group 1, which consists of 24 healthy and fasting volunteers, will receive a tablet with a dose of 250 mg manufactured by Dana Pharmaceutical Company.
Category
N/A

2

Description
Intervention group 2: Intervention group 2, which consists of 24 healthy and fasting volunteers, will receive a tablet with a dose of 250 mg manufactured by Teva Pharmaceutical Company.
Category
N/A

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
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
Daana pharmaceutical company
Full name of responsible person
Ahmad Kharazi
Street address
Daana pharmaceutical company, Zanjan - Tabriz Fwy, Basmanj
City
Tabriz
Province
East Azarbaijan
Postal code
5495151673
Phone
+98 41 3630 0586
Email
name@domain.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Daana 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
Medical Pharmacy
Street address
Drug Applied Research Center, Tabriz University of Medical Sciences
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
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
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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