Bioequivalance study of esomeprazol 40 mg capsules manufactured by sina pishgam daru novin pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Nexium 40 capsules manufactured by AstraZeneca
Comparing pharmacokinetics parameters of Sina pishgam daru novin Esomeprazole 40mg capsules and Nexium 40 mg Capsule of AstraZeneca company.
Design
Bioequivalance study insist of one 24 healthy volunteers group. This group itself randomly divided to two 12 volunteers sub-groups. The first sub-group administered reference drug and the second sub-groups administered generic or test drugs. The bioequivalance study is performed as cross over double blind within 1-2 weeks.
Settings and conduct
Bioequivalance Esomeprazole 40mg study will be performed under physician since 7 AM until 5 PM. This study is carried out as a cross over double blind investigation. The blind person included volunteers, administrator and analyst.
Participants/Inclusion and exclusion criteria
Acceptance criteria: Healthy liver and kidney and observing BMI limits
Rejection criteria: Smokers and pregnancy
Intervention groups
Intervention group insist Measuring maximum plasma concentration and Tmax concentration.Control group include the volunteers administrated reference drugs and Measuring maximum plasma concentration and Tmax concentration.
Main outcome variables
Most important outcome is plasma concentration versus time profile. Pharmacokinetics parameters are calculated using this profile and included Cmax, Tmax, AUC0-t, AUC0-inf
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200513047423N3
Registration date:2021-11-09, 1400/08/18
Registration timing:prospective
Last update:2021-11-09, 1400/08/18
Update count:0
Registration date
2021-11-09, 1400/08/18
Registrant information
Name
Amir Mehdizadeh
Name of organization / entity
Ofogh pajo
Country
Iran (Islamic Republic of)
Phone
+98 21 6673 8727
Email address
ofoghfarmed.lab@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-31, 1400/10/10
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalance study of esomeprazol 40 mg capsules manufactured by sina pishgam daru novin pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with Nexium 40 capsules manufactured by AstraZeneca
Public title
Bio equivalence study of Esomeprazole 40 mg
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy liver
Healthy Kidney
Observing BMI
Exclusion criteria:
Out of age ranges
smoking
Unhealthy liver and kidney
Pregnancy
Age
From 18 years old to 50 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:
1
Each volunteer has been administered once reference drug and the next time test drugs.
Randomization (investigator's opinion)
Randomized
Randomization description
We designate to 24 healthy volunteers one number between 1 and 24.
Extraction of 12 numbers is carried out using random number table available in internet.
these first 12 numbers establish first group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The main investigator creates a table using randomization and divides 24 healthy volunteer in 2 groups which only he knows the details of group.
Test and reference drugs are packaged in special envelopes that administrator and volunteers are blinded regarding to the kind of drugs.
Volunteers, administrator (health care professional) and analyst are blinded regarding to reference and test drugs.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of school of pharmacy and Nurcing &midwiferi-shahid beheshti univercity of medica
Street address
No.65, Razi Ave, Enghelab sq
City
Tehran
Province
Tehran
Postal code
1133713144
Approval date
2021-09-19, 1400/06/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.410
Health conditions studied
1
Description of health condition studied
Bio equivalence Esomeprazole 40 mg
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increasing plasma concentration after administration of esomeprazole capsules till Tmax and then decreasing plasma concentration after Tmax
Timepoint
Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each healthy volunteers.Hence the Tmax of esomeprazole is between 1.5 and 2.5 hours, so it is needed to have 5 blood samplings before Tmax. This period of time is called absorption phase.In the elimination phase (after Tmax)blood sampling carry out each hours.
Method of measurement
In this study, the variable is plasma concentration of esomeprazole. High performance liquid chromatography is used to determine the concentration of esomeprazole in plasma.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: One esomeprazole 40 mg capsule manufactured by sina pishgam daru novin company( Test drug) is administrated to each of 12 healthy volunteers of group 1.
Category
Treatment - Drugs
2
Description
Intervention group 2: One Nexium 40 mg capsule manufactured by AstraZeneca company is administrated to each of 12 healthy volunteers of group 2.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ofoqh pharmed
Full name of responsible person
Dr Amir Mehdizadeh
Street address
No 65, Razi Ave, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1133713144
Phone
+98 21 6673 9211
Email
a_mehdizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sina pishgam daru novin
Full name of responsible person
Dr Naser Arab
Street address
No 28, 4th alley, North Kargar Ave, Tehran
City
tehran
Province
Tehran
Postal code
1413694163
Phone
+98 21 8863 0175
Email
info@sinapishgamdarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sina pishgam darou novin 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
Ofogh pharmed labratory
Full name of responsible person
Dr Amir mehdizadeh
Position
Responsible pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 65, Razi Ave, Enghelab sq
City
Tehran
Province
Tehran
Postal code
1133713144
Phone
+98 21 6673 9211
Email
A_mehdizadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Farzad Kobarfard
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Apart 14, No. 65, Razi Ave, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1133713144
Phone
+98 21 6673 8727
Email
Farzadkf@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ofogh pharmed
Full name of responsible person
Amir Mehdizadeh
Position
Responsible pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Apart 14, No.65, Razi Ave, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1133713144
Phone
+98 21 6673 8727
Email
Ofoghfarmed.lab@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demography tables of volunteers including group 1 and 2 have been shared in bioequivalance report.
When the data will become available and for how long
The results of bioequivalance study of Esomeprazole capsules will be shared after accepting by Iranian food and drug organization.
To whom data/document is available
The results of bioequivalance study of Esomeprazole capsules will be accessed by expert by Iranian food and drug organization and financial supporter.
Under which criteria data/document could be used
To promotion of result of investigation, The results will be shared with eager.
From where data/document is obtainable
1- Iranian food and drug organization, 2- Ofogh pharmed research laboratory
What processes are involved for a request to access data/document
To complied of educational filed of eager to result of investigation