Investigatin Bioequivalence of Quetiapine 100 mg tablet manufactured y Fatak Shimi Co. in compatison to innovator product
Design
Twenty-four healthy male volunteer will enter the study based on random numbers table as two groups of twelve people. Each volunteer will receive a single dose of drug in two periods. In one period the test formulation and in another period the reference formulation (without knowing the formulation identity in each period). Therefore, each volunteer will be his own "Control".
Settings and conduct
After administration of one 100 mg tablet to volunteer, the blood samples will be taken in predetermined time intervals up to 24 hours. The samples will be stored in freezer -4 degrees centigrade until analysis and sample quantitation. In this study the volunteer would not be aware of the formulation identity in each period
Participants/Inclusion and exclusion criteria
Inclusion criteria: General Health (Liver, Heart and Kidney), Age (20-60)
Exclusion criteria: Smoking, history of cardiovascular disease, history of liver and kidney disease, pregnancy, alcohol and drug addiction, history of drug allergy.
Intervention groups
Test group: Administrating the test product
Control group: Administrating the innovator product
In first period, one group of volunteers will receive single dose of Quetiapine 100 mg generic tablet (test formulation) and the second group will receive a single dose of the reference formulation of same drug. After one week wash out period, by cross over design, the first group and second group will administer the reference and test formulations, respectively.
Main outcome variables
Plasma concentration of drug
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210519051345N5
Registration date:2021-10-30, 1400/08/08
Registration timing:prospective
Last update:2021-10-30, 1400/08/08
Update count:0
Registration date
2021-10-30, 1400/08/08
Registrant information
Name
Parvin Zakeri-Milani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 8801
Email address
pzakeri@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-16, 1400/08/25
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In vivo bioequivalence study of Quetiapine 100 mg tablet manufactured by Fatak Shimi Co. in comparison to innovator product
Public title
Bioequivalence study of Quetiapine 100 mg tablet
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: General Health (Liver, Heart and Kidney)
Age (20-60)
Exclusion criteria:
Exclusion criteria:
Smoking,
history of cardiovascular disease, history of liver and kidney disease,
pregnancy,
alcohol and drug addiction
history of drug allergy
Age
From 20 years old to 59 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
"Random number table" will be used. Each volunteer will be assigned a two-digit number. After making the table, we need randomly point to a spot on the table and select the numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, Volunteers participating will be blinded to the type of product they are taking in each period (test or reference product). This means that the product will be given to the volunteers for administration outside the original packaging
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Committe, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, No.2 Central Building, 3rd Floor, Daneshgah st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.TBZMED.REC.1400.636
Health conditions studied
1
Description of health condition studied
In the present study, no diseases will be examined and products will be administered by healthy volunteers.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma Drug Concentration
Timepoint
0.5-24 hours in predetermined time intervals after drug administration
Method of measurement
HPLC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will receive one test drug capsule. Blood samples will be taken from the volunteers for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector.
Category
Treatment - Drugs
2
Description
Control group: Control group will receive one reference drug product. Blood samples will be taken from the volunteers for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be measured by liquid chromatography with mass spectroscopy detector.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Pharmacy, Tabriz University of Medical Sciences
Full name of responsible person
Parvin Zakeri-Milani
Street address
Tabriz University of Medical Sciences, Faculty of Pharmacy, Golgasht st Attar Neishaboori st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
pzakeri@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sameie
Street address
Tabriz University of Medical Sciences, No.2 Central Building 3rd Floor, Daneshgah st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Fatak Shimi Pars Co.
Proportion provided by this source
100
Public or private sector
Public
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
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Zakeri-Milani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz University of Medical Sciences, Faculty of Pharmacy,, Golgasht st Attar Neishaboori st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
pzakeri@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Zakeri-Milani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz University of Medical Sciences, Faculty of Pharmacy, Golgasht st Attar Neishaboori st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
pzakeri@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Zakeri-Milani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Tabriz University of Medical Sciences, Faculty of Pharmacy, Golgasht st Attar Neishaboori st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
pzakeri@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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