In- Vivo Bioequivalence study of Esmoprazole 10 mg Sachet. Teb Mofid Nikan Co.(Pylorinex) with brand drugs (Nexium ® 10 mg Sachet, AstraZeneca, UK) in Iranian healthyvolunteers.
Design
In-vivo bioequivalence study of Esmoprazole 10 mg Sachet Mofid Pharma in comparison with reference drug (Nexium ® 10 mg Sachet, AstraZeneca, UK). The single blind, Cross-over, two period, two groups (Intervention and control) and randomized (paper lottery randomization method) study with one week wash-out time.
Settings and conduct
This study is carried out in Simin Baspar Tayf-Gostar Company, Tabriz, Iran. The study population is 24 healthy Iranian volunteers.This study is a single blind study and by taking out the drugs from the existing packaging, the volunteers will not know the time of receiving the test drug and the brand. This study is a cross over study that is performed in two time periods of 72 hours with a two-week wash-out period.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-60 years old; body mass index (BMI) in the range of 18-28. Exclusion criteria: history of heart, kidney and liver disease; pregnancy; drug addiction.
Intervention groups
Single dose Esmoprazole 10 mg Sachet Mofid Pharma. Control group: Single dose Nexium ® 10 mg Sachet, AstraZeneca, UK
Main outcome variables
Plasma drug concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N71
Registration date:2022-11-21, 1401/08/30
Registration timing:registered_while_recruiting
Last update:2022-11-21, 1401/08/30
Update count:0
Registration date
2022-11-21, 1401/08/30
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
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Esmoprazole 10 mg Sachet. Teb Mofid Nikan Co.(Pylorinex) with brand drugs (Nexium ® 10 mg Sachet, AstraZeneca, UK) in Iranian healthyvolunteers.
Public title
In-vivo Bioequivalence Test of Ibuprofen tablet 800 mg Mofid Pharma with brand drug (Nexium ® 10 mg Sachet, AstraZeneca, UK)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health
Body mass index between18-28
Informed consent
Being at the age of 18-55 years old
Exclusion criteria:
Smoking
A history of cardiovascular disease
A history of liver & kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, A 24- persons group will be selected and divided to two 12-persons groups randomly. The names of all volunteers will be written on paper pieces and wrapped in aluminum foils. The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Candidates are not aware of receiving the test drug or brand one. In a single study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Test and Brand drugs 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 drug.
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
Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2022-10-24, 1401/08/02
Ethics committee reference number
IR.TBZMED.REC.1401.682
Health conditions studied
1
Description of health condition studied
Plasma drug concentration
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma drug concentration
Timepoint
Sampling times in this study will be 0، 0.5، 1، 1.5، 2، 2.5، 3، 3.5، 4، 4.5، 5، 6، 10 .8، 12 , 24 hours after prescribing the tablet.
Method of measurement
High Performance Liquid Chromatography with tandem mass spectroscopy detector
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One test Sachet (Esmoprazole 10 mg Sachet. Teb Mofid Nikan Co.) will be received. Blood samples will be taken for 48 hours at the mentioned times after drug administration and the concentration of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector
Category
Treatment - Other
2
Description
Control group: One Reference tablet Nexium ® 10 mg Sachet, AstraZeneca, UK will be received. Blood samples will be taken for 24 hours at the mentioned times after drug administration and the concentration of drug in plasma samples will be measured by liquid chromatography with mass spectroscopy detector.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Simin Baspar Teyf Gostar Company
Full name of responsible person
Javad Shokri
Street address
No. 10, 18-meter Mihrab St., Mirdamad St
City
Tabriz
Province
East Azarbaijan
Postal code
5166934184
Phone
+98 41 3384 3199
Email
Shokri.j@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Teb Mofid Nikan Pharmaceutical Co.
Full name of responsible person
Mohammad Reza Zargarzadeh
Street address
No. 275, Shafayab Building, 6th Floor, Beheshti St., Tehran
City
Tehran
Province
Tehran
Postal code
3361658369
Phone
+98 21 8817 5765
Email
info@mofidpharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Teb Mofid Nikan Pharmaceutical 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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Simin Baspar Teyf Gostar Company
Full name of responsible person
Dariush Omidfar
Position
Lab. Manager
Latest degree
Master
Other areas of specialty/work
Bioanalysis
Street address
No. 10, 18-meter Mihrab St., Mirdamad St
City
Tabriz
Province
East Azarbaijan
Postal code
5166934184
Phone
+98 41 3384 3199
Email
Dariush.omidfar@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
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5166934184
Phone
+98 41 3384 3199
Email
Shokri.j@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Simin Baspar Teyf Gostar Company
Full name of responsible person
Ahad Sheikhloo
Position
Official Manager
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
No. 10, 18-meter Mihrab St., Mirdamad St
City
Tabriz
Province
East Azarbaijan
Postal code
5166934184
Phone
+98 41 3384 3199
Email
ahad.sheikhloo@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
All information and data of the study will remain secured based on the agreement established between researcher and drug producer.
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
Undecided - It is not yet known if there will be a plan to make this available