In vivo fasted-state bioequivalence study of Valacyclovir 100 mg tablet
Design
The clinical trial has control and test groups with crossover, randomized design, without blinding. Twenty-four healthy male volunteers will participate randomly in the study as two twelve-person study groups. Each volunteer will receive a single oral dose of drug in fasted state in two periods. To randomly assign participants in two groups, the lottery method will be used.
Settings and conduct
After oral administration of one 1000 mg tablet, the blood samples will be collected in predetermined time intervals up to 12 hours. The samples will be stored in freezer -4 degrees centigrade until analysis. 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. This study will be conducted without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: General Health (in terms of Liver, Heart and Kidney), Age (18-59 years old) Exclusion criteria: Smoking, Pregnancy, Alcohol and drug addiction, History of drug allergy.
Intervention groups
Intervention group will receive a single oral dose of test product (Valacyclovir 1000 mg of Sobhan Co.) and Control group will receive a single dose of reference product (Valacyclovir 1000 mg of Glaxo Smith Kline). Blood samples will be taken for 12 hours 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. After a week, the test and control group will be exchanged and will receive the drug of second manufacturer.
Main outcome variables
Drug plasma concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220211053992N9
Registration date:2023-05-30, 1402/03/09
Registration timing:prospective
Last update:2023-05-30, 1402/03/09
Update count:0
Registration date
2023-05-30, 1402/03/09
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
2023-06-15, 1402/03/25
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of Valacyclovir 1000 mg tablet manufactured by Sobhan Darou Co. compared with innovator product
Public title
Investigating the in vivo bioequivalence of Valacyclovir tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
General Health (in terms of Liver, Heart and Kidney)
Age (18-59 years old)
Exclusion criteria:
Smoking
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
No.2 Central Building 3rd Floor, Tabriz University of Medical Sciences, Daneshgah st.
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Approval date
2022-05-22, 1401/03/01
Ethics committee reference number
IR.TBZMED.REC.1402.166
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
Befor drug administration in time zero and also In 0.5, 1,1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 hours 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 (Valacyclovir 1000 mg tablet manufactured by Sobhan Co.) in fasted state. Blood samples will be collected for 12 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. After a week, the test and control group will be exchanged and will receive the drug of second manufacturer.
Category
Treatment - Drugs
2
Description
Control group: Control group will receive a single oral dose of reference product (Valacyclovir 1000 mg tablet manufactured by Glaxo Smith Kline Co.) in fasted state. Blood samples will be collected for 12 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. After a week, the test and control group will be exchanged and will receive the drug of second manufacturer.
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, 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
Sobhan darou Pharmaceutical 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, Golgasht st Attar Neishaboori st.
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, Tabriz University of Medical Sciences, Golgasht st Attar Neishaboori st.
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, Tabriz University of Medical Sciences, Golgasht st Attar Neishaboori st.
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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available