Comparative bioequivalence study of two different Omeprazole 20 mg formulations (Zagros Darou Pharmaceutical Company & reference) in 24 Iranian volunteers
Evaluation of bioequivalence of a Omeprazole capsule manufactured by Zagros Darou Pharmaceutical Company with its reference sample
Design
Bioequivalency study of Omeprazole capsule manufactured by Zagros Darou Pharmaceutical Company and reference product in 24 healthy volunteers. This study was cross-over, random, and double-blind. Excel rand function was used for randomization
Settings and conduct
This study is carried out in the central laboratory of the Hamadan School of Pharmacy. The 24 volunteers are randomly divided into two groups and are divided into two stages of the study. This study is double-blind and the recipient and analyzer will not be in the process of consuming the product. Blood samples will be collected from each volunteer at specified times for 24 hours. The method used to measure the amount of drug in the samples of volunteers will be performed using high-performance liquid chromatography and an ultraviolet detector.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ages 18 to 45 years, Actual weight (TBW) in the range of 20% IBW, Non-smoker
Intervention groups
Administration of omeprazole capsule product made in Zagros Daru Pharmaceutical company to evaluate the pharmacokinetic parameters of the drug and then compare it with the reference drug 2. Administration of omeprazole capsule formulated at Sandoz pharmaceutical company to evaluate the pharmacokinetic parameters of the drug and then compare it with the test drug
Main outcome variables
Omperazole plasma concentration; Area under the curve; Half-life time; Time to reach maximum plasma concentration; Maximum concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111107008022N12
Registration date:2024-04-06, 1403/01/18
Registration timing:prospective
Last update:2024-04-06, 1403/01/18
Update count:0
Registration date
2024-04-06, 1403/01/18
Registrant information
Name
Katayoun Derakhshandeh
Name of organization / entity
Hamadan University of Medical Sciences, Pharmacy school
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1590
Email address
kderakhshandeh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-09, 1403/02/20
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of two different Omeprazole 20 mg formulations (Zagros Darou Pharmaceutical Company & reference) in 24 Iranian volunteers
Public title
Bioequivalence study of two different Omeprazole formulations
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy male and female volunteers
Aged 18 to 45 years
Based on laboratory safety tests
no history of diseases affecting drug pharmacokinetic processes
lack of any chronic or acute medication at least 1 week before the start of the study
Actual weight (TBW) in the range of 20% IBW
Exclusion criteria:
Subject showed clinically relevant deviations from normal in physical examination
Subject had undergone surgery of the gastrointestinal tract
Subject had donated a unit of blood or participated in another clinical trial, within the last three months before the first treatment
Subject had a history of alcohol abuse or smokes more than 10 cigarettes per day
Use any medication within 14 days before the first treatment
Age
From 20 years old to 40 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 24 volunteers were randomly divided into two groups of 12 test (A) and reference (B) drug recipients by Excel software, then in the second phase, groups A and B will be cross-referenced to the test and drug recipients.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this project, the volunteers, person responsible for blood sampling and analyzer are kept blind. To blind these people, all the information collected is coded to the researcher, and after the analysis is completed, codes will be opened
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committees of Hamadan University of Medical Sciences
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Beside Mardom amusement Park, Shahid Fahmideh Blvd, Hamadan , Iran
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2024-02-24, 1402/12/05
Ethics committee reference number
IR.UMSHA.REC.1402.719
Health conditions studied
1
Description of health condition studied
Health and normal volunteers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug plasma concentration
Timepoint
Blood samples were collected at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour following drug administration
Method of measurement
Using High Performance Liquid Chromatography instrument
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zagrous Darou 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Katayoun Derakhshandeh
Position
Professor of Pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hamadan University of Medical Sciences, Faculty of Pharmacy
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1590
Email
k.derakhshandeh@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hidapharma company
Full name of responsible person
Dr. Mehrdad Hamidi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Unit #2, No. 35, Hosseini Rad Alley, Next ot Motahari St.,Valiasr Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۵۹۵۸۱۴۳۱۳
Phone
+98 21 8885 1172
Email
info@hidapharma.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Katayoun Derakhshandeh
Position
Professor of Pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Hamadan University of Medical Sciences, Shaheed Fahmideh Blvd., In front of Mardom Park, Hamadan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1590
Email
k.derakhshandeh@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
The pharmacokinetic data obtained from the study are for each volunteer in both the test and reference groups
When the data will become available and for how long
6 months after the end of the study
To whom data/document is available
All researchers and clinical specialists
Under which criteria data/document could be used
There is no denial of access to data
From where data/document is obtainable
The results of the project are reported in the form of a published paper. Article will be available after it is published. If needs quicker access to the results, can reach us at "k.derakhshandeh@umsha.ac.ir"
What processes are involved for a request to access data/document
There will be no problem accessing results when publishing results in online articles. The wait time to access the results will be 3 months after the project is completed. If needs quicker access to the results, can reach us at "k.derakhshandeh@umsha.ac.ir".