Evaluation of pharmacokinetic parameters and in vitro bioequivalence study of generic desloratadine 5 mg tablets manufactured by Poorsina Pharmaceutical Company with brand drug in a cross-over and double-blind study in healthy Iranian volunteers.
Evaluation of pharmacokinetic parameters and in vitro bioequivalence study of generic desloratadine 5 mg tablets manufactured by Poorsina Pharmaceutical Company with brand drug in a cross-over and double-blind study in healthy Iranian volunteers.
Design
The study will be done cross-over and double-blind.
Settings and conduct
The study will be conducted in a cross-over and double-blind manner in healthy Iranian volunteers
Participants/Inclusion and exclusion criteria
All volunteers should be non smoking; All volunteers should have generally (kidney, liver, respiratory system and neuropsychology) health; All volunteers should Informed consent.
Intervention groups
Prescribing two brands of drugs to healthy volunteers
Main outcome variables
Different intestinal absorption, different metabolism, different excretion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231108059993N1
Registration date:2024-07-09, 1403/04/19
Registration timing:registered_while_recruiting
Last update:2024-07-09, 1403/04/19
Update count:0
Registration date
2024-07-09, 1403/04/19
Registrant information
Name
Iran Ghanbarzadeh
Name of organization / entity
Alborz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 41 3383 2649
Email address
s_ghanbarzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-08, 1403/04/18
Expected recruitment end date
2025-01-07, 1403/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pharmacokinetic parameters and in vitro bioequivalence study of generic desloratadine 5 mg tablets manufactured by Poorsina Pharmaceutical Company with brand drug in a cross-over and double-blind study in healthy Iranian volunteers.
Public title
Bioequivalence study of Iranian drugs with brand drugs
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
All volunteers should be non smoking.
All volunteers should have generally (kidney, liver, respiratory system and neuropsychology) health.
All volunteers should Informed consent.
Exclusion criteria:
Having special diseases.
being smoker.
Using drugs with contractions with des loratadine.
Having liver and kidney diseases.
Age
From 18 years old to 60 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Only the researcher knows who will use which drug brand.
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
Tabriz, Azadi Ave, Golgasht Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5159115705
Approval date
2024-06-24, 1403/04/04
Ethics committee reference number
IR.TBZMED.REC.1403.257
Health conditions studied
1
Description of health condition studied
Healthy volunteers
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
drug blood concentration
Timepoint
4 weeks
Method of measurement
HPLC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One group will take the domestic brand drug and the other group will take the foreign brand drug and after 4 weeks the used drug brand will be changed in the groups.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Payesh daroo zist azma Laboratory
Full name of responsible person
Saeed Ghanbarzadeh
Street address
No 10, Mehrab Ave, Mirdamad
City
Tabriz
Province
East Azarbaijan
Postal code
5166934184
Phone
+98 41 3383 2649
Email
PayeshDarou@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Poorsina Pharmaceutical Company
Full name of responsible person
Abbas Montazer
Street address
Tehran Karaj road 22 Km
City
Tehran
Province
Tehran
Postal code
1399133351
Phone
+98 21 4498 6873
Email
info@pursinapharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Poorsina 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
Daroo Shimi Teb Sanjesh Company
Full name of responsible person
Saeed Ghanbarzadeh
Position
PhD of Pharmaceutics, Quality Control Manager in Shahid Ghazi Pharmaceutical Company
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 10, Sajjadieh Alley, Pastoor Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138936664
Phone
+98 41 3476 9144
Email
s_ghanbarzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Daroo Shimi Teb Sanjesh Company
Full name of responsible person
Saeed Ghanbarzadeh
Position
Quality Control Manager in Shahid Ghazi Pharmaceutical Company
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 10, Sajjadieh Alley, Pastoor Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138936664
Phone
+98 41 3476 9144
Email
s_ghanbarzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Daroo Shimi Teb Sanjesh
Full name of responsible person
Saeed Ghanbarzadeh
Position
Chairman of the Board
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 10, Sajjadieh Ale, Pastoor Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5138936664
Phone
+98 41 3476 9144
Email
s_ghanbarzadeh@yahoo.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
Privacy of people's profile and test data
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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 informed consent form of the midwife has been submitted to the Ethics Committee of Tabriz University of Medical Sciences. The clinical study report will be submitted to the Food and Drug Organization.
When the data will become available and for how long
2024-2025Food and Drug Organization
To whom data/document is available
Food and Drug Organization
Under which criteria data/document could be used
With Permission of Food and Drug Organization
From where data/document is obtainable
Food and Drug Organization
What processes are involved for a request to access data/document