Bioequivalence study of dapagliflozin 10 mg tablet of Viana Darou Sanat pharmaceutical company compared to dapagliflozin 10 mg sample of AstraZeneca company in Australia on healthy volunteers
Bioequivalence study of dapagliflozin 10 mg tablet of Viana Darou Sanat pharmaceutical company compared to dapagliflozin 10 mg sample of AstraZeneca company in Australia on healthy volunteers
Design
The present clinical trial includes the study of the bioequivalence of dapagliflozin 10 mg tablets of Viana Darou Sanat pharmaceutical company in Iran compared to the sample of dapagliflozin 10 mg of AstraZeneca company in Australia, after administration to 24 healthy human volunteers, in two intervention groups, cross-over. It is not blinded and non-randomized.
Settings and conduct
The study is carried out at Nik Azma Pars Alborz company located in Mahdasht Karaj. The blinded cross-over study includes two stages (oral consumption of one 10 mg dapagliflozin tablet per study and 2 times in total) with a one-week washout period on 24 fasting healthy volunteers. Then the obtained blood samples are determined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy volunteers; Age between 18 and 55 years; non smoker;
Exclusion criteria: candidates with blood pressure less than 90 on 60 mm Hg or higher than 140 on 90 mm Hg.
Intervention groups
The study includes two stages as an intervention 1: including oral consumption of dapagliflozin 10 mg tablets of Viana Darou Sanat Pharmaceutical Company in Iran and
Intervention 2: Taking dapagliflozin 10 mg tablets of AstraZeneca company in Australia. This study will be repeated on fasting volunteers in a cross-sectional manner with an interval of one week.
Main outcome variables
The maximum plasma concentration of dapagliflozin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057495N18
Registration date:2024-06-12, 1403/03/23
Registration timing:prospective
Last update:2024-06-12, 1403/03/23
Update count:0
Registration date
2024-06-12, 1403/03/23
Registrant information
Name
Monireh Jalalipour
Name of organization / entity
Nikazma Pars Alborz company
Country
Iran (Islamic Republic of)
Phone
+98 26 3731 8748
Email address
info@naplab.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of dapagliflozin 10 mg tablet of Viana Darou Sanat pharmaceutical company compared to dapagliflozin 10 mg sample of AstraZeneca company in Australia on healthy volunteers
Public title
Bioequivalence study of dapagliflozin 10 mg tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteer between 18 and 55 years old.
Body mass index less than 30 kg per square meter.
All candidates must be non-smokers.
Exclusion criteria:
Blood pressure less than 90 on 60 mm Hg or more than 140 on 90 mm Hg.
Consumption of any drug, alcohol or tobacco within 2 weeks before receiving the drug.
Age
From 18 years old to 55 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
No information
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
36
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Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences
Street address
Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Tehran University of Medical Sciences, Porsina Street
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-05-11, 1403/02/22
Ethics committee reference number
IR.TUMS.TIPS.REC.1403.020
Health conditions studied
1
Description of health condition studied
---
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The maximum plasma concentration of dapagliflozin
Timepoint
before starting to take the drug and: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 24 36 and 48 hours after taking the drug
Method of measurement
Liquid chromatography-mass spectrometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: It includes the oral intake of dapagliflozin 10 mg tablets of Viana Darou Sanat pharmaceutical company in Iran on 24 healthy fasting volunteers. 5 ml of blood at time intervals before starting the medication and: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 24, 36 and 48 hours after taking the drug, it is taken from the volunteers. The cross-over study consists of two phases (oral administration of one dapagliflozin 10 mg tablet per study and 2 times in total) with a one-week washout period (when the drug is completely removed from your blood). Determining the plasma concentration of dapagliflozin is done by liquid chromatography-mass spectrometry.
Category
Other
2
Description
Intervention group 2: includes the oral intake of dapagliflozin 10 mg tablets of AstraZeneca, Australia, on 24 healthy fasting volunteers. 5 ml of blood at time intervals before starting the medication and: 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 24, 36 and 48 hours after taking the drug, it is taken from the volunteers. The cross-over study consists of two phases (oral administration of one dapagliflozin 10 mg tablet per study and 2 times in total) with a one-week washout period (when the drug is completely removed from your blood). Determining the plasma concentration of dapagliflozin is done by liquid chromatography-mass spectrometry.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Nik Azma Pars Alborz Laboratory
Full name of responsible person
Monireh Jalalipour
Street address
No. 419, Azadegan Square, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Viana Darou Sanat Pharmaceutical company
Full name of responsible person
Mohammad Masoud Samadian Zahraii
Street address
Plot No. 181, Barkat Pharmaceutical Industrial Estate, Barkat St., Kilometer 10 of Azad Karaj-Qazvin Road
City
Karaj
Province
Alborz
Postal code
3365111273
Phone
+98 26 3403 3813
Email
info@vianapharma.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Viana Darou Sanat 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
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Azadegan Square, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Azadegan Square, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.ir
Person responsible for updating data
Contact
Name of organization / entity
Nik Azma Pars Alborz laboratory
Full name of responsible person
Monireh Jalalipour
Position
Responsible Pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 419, Azadegan Squar, Imam Khomeini Boulevard
City
Mahdasht Karaj
Province
Alborz
Postal code
3188913179
Phone
+98 26 3731 8748
Email
info@naplab.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