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In vivo bioequivalence study of Dolutegravir 50 mg tablets manufactured by Bakhtar Bioshimi Co. compared to innovator product

Protocol summary

Study aim
In vivo fasted-state bioequivalence study of Dolutegravir tablet
Design
The clinical trial has control and test groups with crossover, randomized design, without blinding. 24 healthy male volunteers will participate randomly in the study as two twelve-person groups. Each volunteer will receive a single tablet in two periods. In one period the test and in another period the reference formulation. Therefore, each volunteer will be his own "Control". To randomly assign participants in two groups, the lottery method will be used.
Settings and conduct
After oral administration of one tablet of Dolutegravir to volunteer, the blood samples will be collected in predetermined time intervals up to 48 hours. The plasma samples will be stored in freezer -4 degrees centigrade until analysis and sample quantitation. The concentration of drug will be measured by HPLC with mass spectroscopy detector. The study will be performed without blinding 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 of 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 one tablet of Dolutegravir manufactured by Bakhtar Bioshimi Co. and Control group will receive one tablet of Dolutegravir manufactured by Mylan Co. Blood samples will be taken for 48 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
Plasma drug concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220211053992N36
Registration date: 2024-06-22, 1403/04/02
Registration timing: prospective

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
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
2024-07-10, 1403/04/20
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In vivo bioequivalence study of Dolutegravir 50 mg tablets manufactured by Bakhtar Bioshimi Co. compared to innovator product
Public title
In vivo Bioequivalence study of Dolutegravir tablets
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (in terms of Liver, Heart and Kidney diseases) Age between 18 to 59 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
Both
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
No.2 Central Building 3rd Floor, Tabriz University of Medical Sciences, Daneshgah st.
City
تبریز
Province
East Azarbaijan
Postal code
51664-14766
Approval date
2024-06-10, 1403/03/21
Ethics committee reference number
IR.TBZMED.REC.1403.197

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
0.5-48 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 one tablets of test product (Dolutegravir 50 mg manufactured by Bakhtar Bioshimi Co.) in fasted state. Blood samples will be collected for 48 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 one tablet of reference product Dolutegravir 50 mg tablet manufactured by Mylan Co.) in fasted state. Blood samples will be collected for 48 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., Golgash 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, Tabriz 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
Exir Co.
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, 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
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, 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
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, 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
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
Analytic Code
Not applicable
Data Dictionary
Not applicable
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