In vivo fasted-state bioequivalence study of Atomoxetine 40 mg
Design
Twenty-four healthy male volunteers will participate in the study as two twelve-person study groups. 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. Therefore, each volunteer will be his own "Control".
Settings and conduct
After oral administration of one 40 mg capsule to volunteer, the blood samples will be collected in predetermined time intervals up to 24 hours. The samples will be stored in freezer -4 degrees centigrade until analysis and sample quantitation. The concentration of drug in blood samples will be measured by liquid chromatography equipped with mass spectroscopy detector. The study will be performed in Faculty of Pharmacy, ،Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: General Health (in terms of Liver, Heart and Kidney diseases), Age (18-59 years old) Exclusion criteria: Smoking, History of cardiovascular disease, liver and kidney disease, Pregnancy, Alcohol and drug addiction, History of drug allergy
Intervention groups
Intervention group will receive a single oral dose of test drug product (Atomoxetine 40 mg manufactured by Hakim, Iran) and Control group will receive a single dose of reference drug product (Atomoxetine 40 mg manufactured by Lili, Switzerland). Blood samples will be taken from the volunteers for 24 hours at the mentioned time points after drug administration and the plasma will be stored in freezer until analysis. . In both groups, breakfast and lunch will be served two and six hours after drug administration, respectively)
Main outcome variables
Drug plasma concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220211053992N5
Registration date:2022-12-24, 1401/10/03
Registration timing:prospective
Last update:2022-12-24, 1401/10/03
Update count:0
Registration date
2022-12-24, 1401/10/03
Registrant information
Name
Hadi Valizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 8801
Email address
valizadehh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-20, 1401/10/30
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In vivo Bioequivalence study of Atomoxetine 40 mg capsule manufactured by Pursina Pharmaceutical Co. Compared to innovator Product
Public title
In vivo bioequivalence study of Atomoxetine capsule
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (in terms of Liver, Heart and Kidney diseases)
Age between 18 to 60 years
Exclusion criteria:
Smoking,
History of cardiovascular, liver, and kidney disease
Pregnancy
Alcohol and drug addiction
History of drug allergy
Age
From 18 years old to 59 years old
Gender
Male
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
To randomly assign participants in two groups, 24 cards with numbers 1 to 24 will be used in closed envelopes that are arranged irregularly. Each candidate will pick up an envelope. Numbers 1-12 will be in group A and numbers 13-24 will be in group B. Group A will receive intervention 1 and group B will receive intervention 2, and after the first period, the interventions of both groups will change for the second period.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Faculty of Pharmacy, University of Medical Sciences,Golgasht st Attar Neishaboori st. Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Approval date
2022-12-19, 1401/09/28
Ethics committee reference number
IR.TBZMED.REC.1401.852
Health conditions studied
1
Description of health condition studied
In the present study, the products will be administered to healthy volunteers.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Plasma concentration of drug
Timepoint
0.5-24 hours in predetermined time intervals after drug administration
Method of measurement
HPLC (High performance liquid chromatography)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group will receive a single oral dose of test product (Atomoxetine 40 mg capsule manufactured by Hakim Co., Iran) in fasted state. Blood samples will be collected for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be stored in freezer until analysis. Breakfast and lunch will be served two and six hours after drug administration, respectively.
Category
Treatment - Drugs
2
Description
Control group: Control group will receive a single oral dose of reference product (Atomoxetine 40 mg capsule manufactured by Lili, Switzerland) in fasted state. Blood samples will be collected for 24 hours at the mentioned times after drug administration and the concentration of drug in blood samples will be stored in freezer until analysis. Breakfast and lunch will be served two and six hours after drug administration, respectively.
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
Hadi Valizadeh
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Attar Neishaboori st., Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
+98 41 3334 4798
Email
valizadehh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
No.2 Central Building 3rd Floor, University of Medical Sciences, Daneshgah st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Fax
+98 41 3334 4798
Email
shahabip@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hakim 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
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Valizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University of Medical Sciences, Golgasht st Attar Neishaboori st. Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
valizadehh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Valizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University of Medical Sciences,Golgasht st Attar Neishaboori st. Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
valizadehh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Valizadeh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University of Medical Sciences,Golgasht st Attar Neishaboori st. Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3334 8801
Email
valizadehh@gmail.com
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