Bioequivalance study of Famotidine 40 mg tablets manufactured by Fatak Chemie pars pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with famotidine tablets manufactured by Ratiopharm.
Comparing pharmacokinetics parameters of Fatak chemie pars Famotidine 40 mg tablets and Famotidine 40 mg tablet of Ratiopharm German.
Design
Bioequivalance study insists of one 24 healthy volunteers group.
This group itself randomly divided to two 12 volunteers sub-groups.
The first sub-groups administrated reference drug and the second sub-groups administrated generic or test drugs.
The bioequivalance study is performed as cross over double blind within 1-2 weeks.
Settings and conduct
Bioequivalance Famotidine 40mg study will be performed under physician since 7 Am until 7 Pm. This study is carried out as a cross over double blind investigation. The blind person include volunteers, administrator and analyst.
Participants/Inclusion and exclusion criteria
Acceptance criteria: Healthy liver,Healthy kidney,Volunteers should not be too fat or too thin and their weight index should be in the appropriate range
Rejection criteria: Smokers and pregnancy.
Intervention groups
Intervention consists of administration of one Famotidine 40 mg tablet of FATAK CHIMIE PARS company as TEST PRODUCT to the first twelve group in this cross-study and simultaneously administration of one Famotidine 40 mg tablet of RATIOPHARM company as REFERENCE PRODUCT to the second twelve group as control group.
Main outcome variables
Plasma concentration of famotidine is the main consequence, its concentration at Tmax reaches about 200 ng/mL and its measurement range is from 10ng / mL to 700ng / mL.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200513047423N5
Registration date:2021-11-29, 1400/09/08
Registration timing:retrospective
Last update:2021-11-29, 1400/09/08
Update count:0
Registration date
2021-11-29, 1400/09/08
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
2021-11-05, 1400/08/14
Expected recruitment end date
2021-11-26, 1400/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalance study of Famotidine 40 mg tablets manufactured by Fatak Chemie pars pharmaceutical company on 24 healthy volunteers and comparing pharmacokinetics results with famotidine tablets manufactured by Ratiopharm.
Public title
Bioequivalance study of Famotidine 40 mg
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy liver
Healthy kidney
Volunteers should not be too fat or too thin and their weight index should be in the appropriate range
Exclusion criteria:
Out of age ranges
smoking
pragnancy
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 volunteers has been administrated one reference drug and 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 https://kitset.ir/numbers/random#random-number-form.
These first 12 random numbers create the 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 Iran University of Medical Sciences
Street address
Apart 14, No. 65, Razi St., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1133713144
Approval date
2021-10-05, 1400/07/13
Ethics committee reference number
IR.IUMS.REC.1400.625
Health conditions studied
1
Description of health condition studied
Bioequivalance Famotidine 40 mg
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
plasma concentration changing after administration of Famotidine tablet.Plasma concentration of famotidine at Tmax reaches about 200 ng/mL and its measurement range is from 10ng / mL to 700ng / mL
Timepoint
Initial blood sampling is performed before drug administration to obtain blank plasma chromatogram of each volunteers. Hence the Tmax of Famotidine is between 1 and 3 hours, so it is needed to have 5 blood sampling 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 famotidine. High performance liquid chromatography is used to determine the concentration of famotidine in plasma.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: One Famotidine 40 mg tablet manufactured by Fatak chemie pars company (Test drug) is administrated to each of 12 healthy volunteer of group 1.
Category
Behavior
2
Description
Intervention group 2: One Famotidine 40 mg tablets manufactured by Ratiopharm German company is administrated to each o 12 healthy volunteers of group 2.
Category
Behavior
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, Enqhelab Ave
City
Tehran
Province
Tehran
Postal code
1133713144
Phone
+98 21 6673 8727
Email
a_mehdizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fatak chemie pars Pharmacy
Full name of responsible person
Dr Reza hadavi
Street address
No13, Second alley, Pakestan Ave, Beheshti Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1531636319
Phone
+98 21 8873 8441
Email
info@fatakchemie.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Fatak chemie pars
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
Ofoqh pharmed labratory
Full name of responsible person
Dr Amir mehdizahed
Position
Responsible pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Apart 14, No. 65, Razi Ave, Enqhelab Ave
City
Tehran
Province
Tehran
Postal code
1133713144
Phone
+98 21 6673 8727
Email
A_mehdizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr setareh Akbari
Position
Consultant
Latest degree
Medical doctor
Other areas of specialty/work
Medical Ethics
Street address
No.65, Razi Ave, Enghelab Ave
City
Tehran
Province
Tehran
Postal code
1133713144
Phone
+98 21 8862 2578
Email
a_mehdizade@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ofoqh pharmed
Full name of responsible person
Amir mehdizadeh
Position
Responsible pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No.65, Razi Ave., Enqelab Ave.
City
Tehran
Province
Tehran
Postal code
1133713144
Phone
+98 21 6673 8727
Email
a_mehdizadeh@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 Famotidine tablets will be shared after accepting by Iranian food and drug organization.
To whom data/document is available
The results of bioequivalance study of Famotidine tablets 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 farmed laboratory
What processes are involved for a request to access data/document
To complied of educational filed of eager to result of investigation.