This study, as part of the curriculum of bioequivalence tests of domestic production, evaluates the bioequivalence of 40 mg Pantoprazole entric coated tablet manufactured by Exir Pharmaceutical Company with its reference sample
Design
Bioequivalency study of Pantoprazole 40 mg tablet (Exir Pharmaceutical Company) and reference product of Pantozol (Takeda Company) are evaluated in 24 healthy volunteers. This study was cross-over, random, and double-blind.
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 infrared detector.
Participants/Inclusion and exclusion criteria
Ages 18 to 45 years, Real weight (TBW) in the range of + -20% ideal weight, Non-smoker
Intervention groups
1. Enteric coated tablets of Pantoprazole formulated at Exir Pharmaceutical company
2. Enteric coated tablets of Pantoprazole formulated at Takeda company
Main outcome variables
Metformin 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:IRCT20111107008022N8
Registration date:2022-01-28, 1400/11/08
Registration timing:registered_while_recruiting
Last update:2022-01-28, 1400/11/08
Update count:0
Registration date
2022-01-28, 1400/11/08
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
2022-01-28, 1400/11/08
Expected recruitment end date
2022-02-11, 1400/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative bioequivalence study of two different Pantoprazole 40mg formulations (Exir Pharmaceutical Company & reference) in 24 Iranian volunteers
Public title
Bioequivalency study of two different Pantoprazole formulations
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
24 healthy male and female volunteers will participate in this study
Aged 18 to 45 years based on laboratory safety tests
Paraclinical health based on tests performed
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
Adherence to the criteria on the basis of moral obligation and signed an informed consent
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 gastro-intestinal 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.
A history of allergic to biguanides
Age
From 20 years old to 40 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
Each participant in each study period will receive a single dose of test and reference formulations
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.
Randomization method:
First I create a Microsoft Excel worksheet, in column 1 I write the number of candidates (1 to 24). In the second column, we write the groups in which the samples are placed (reference and test). 12 The first sample as a reference and the next 12 samples as a test sample. In column 3, we add the randomization formula (a function called RAND).
Filter the contents of column 3 in ascending or descending order to make it random. Finally, the number of candidates is divided into two groups: reference and test.
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
Hamadan University of Medical Sciences, Beside Mardom amusement Park, Shahid Fahmideh Blvd, Hamadan , Iran
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2022-01-21, 1400/11/01
Ethics committee reference number
IR.UMSHA.REC.1400.846
Health conditions studied
1
Description of health condition studied
Health 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 and 12 h following drug administration
Method of measurement
Using HPLC instrument
Secondary outcomes
1
Description
Pharmacokinetic parameters: Half-life, Cmax The peak plasma concentration of a drug after administration, The volume of distribution, and Clearance
Drug analysis in plasma using a chromatographic apparatus and calculating pharmacokinetic parameters using pharmacokinetic models
Intervention groups
1
Description
Intervention group: Oral administration of a single dose of 40 mg pantoprazole tablets made by Takeda company to 12 volunteers in two periods. The interval between two periods, called washout is the time when the drug is removed from the body and its duration is calculated as 5 to 7 half-lives of the drug.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Pharmacy, Hamadan University of Medical Sciences
Full name of responsible person
Katayoun Derakhshandeh
Street address
Faculty of Pharmacy, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1590
Fax
+98 81 3838 1591
Email
k.derakhshandeh@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Exir Pharmaceutical Company
Full name of responsible person
Mohsen Kordi
Street address
Borojerd, 2 Km of ring road
City
Borojerd
Province
Lorestan
Postal code
69189
Phone
+98 66 4260 6022
Email
info@exir.co.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir 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
Katayoun Derakhshandeh
Position
Profof Pharmaceutics
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Pharmaceutics, School of Pharmacy, Hamadan University of Medical Sciences, Hamadan
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
Hamedan University of Medical Sciences
Full name of responsible person
Katayoun Derakhshandeh
Position
Prof. 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
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
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
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".