Bioequivalence study of aripiprazole 5 mg tablet from Kimidaro Pharmaceutical Company compared to aripiprazole 5 mg sample from Otsuka Pharmaceutical Netherlands B.V. United Kingdom on healthy volunteers
Bioequivalence study of aripiprazole 5 mg tablet of Kimidarou pharmaceutical company in comparison with the same sample made by Otsuka Pharmaceutical Netherlands B.V company in England on healthy volunteers.
Design
The present clinical trial includes the bioequivalence study of aripiprazole 5 mg tablets produced by Kimidarou Pharmaceutical Company in comparison with the sample of aripiprazole 5 mg produced by Otsuka Pharmaceutical Netherlands B.V., United Kingdom, after administration to 24 healthy human volunteers, in two intervention groups, in a cross-over manner. , is not blinded and non-randomized.
Settings and conduct
The study is carried out at Nik Azma Pars Alborz company located in Mahdasht Karaj, Imam Khomeini Blvd., Azadegan Square, No. 419. The study is cross-blinded, including two stages (oral intake of a 5 mg aripiprazole tablet per study and in total 2 times) with a seven-week washing period on 24 fasting healthy volunteers. Blood samples are taken from the volunteers at certain intervals of drug consumption, and then the amount of aripiprazole in plasma is determined by liquid chromatography-mass spectrometry.
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy volunteers between the ages of 18 and 65 should be non-smokers. Exclusion criteria: volunteers with blood pressure less than 90 over 60 mm Hg or higher than 140 over 90 mm Hg.
Intervention groups
The study includes two stages as intervention 1: It includes the oral intake of Aripiprazole 5 mg tablets manufactured by Kimidarou Pharmaceutical Company in Iran and Intervention 2: The oral intake of Aripiprazole 5 mg tablets manufactured by Otsuka Pharmaceutical Netherlands B.V. in the United Kingdom. This study will be repeated on fasting volunteers in a cross-sectional manner with an interval of seven weeks.
Main outcome variables
Maximum plasma concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230222057495N6
Registration date:2023-06-11, 1402/03/21
Registration timing:registered_while_recruiting
Last update:2023-06-11, 1402/03/21
Update count:0
Registration date
2023-06-11, 1402/03/21
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
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Bioequivalence study of aripiprazole 5 mg tablet from Kimidaro Pharmaceutical Company compared to aripiprazole 5 mg sample from Otsuka Pharmaceutical Netherlands B.V. United Kingdom on healthy volunteers
Public title
Bioequivalence study of aripiprazole 5 mg tablet
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy volunteers aged between 18 and 65 years
All candidates must be non-smokers
Body mass index less than 30 kg per square meter
Exclusion criteria:
Blood pressure less than 90 over 60 mm Hg or more than 140 over 90 mm Hg
Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug
Age
From 18 years old to 65 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:
34
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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
2023-06-10, 1402/03/20
Ethics committee reference number
IR.TUMS.TIPS.REC.1402.039
Health conditions studied
1
Description of health condition studied
---
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Maximum plasma concentration of Aripiprazole
Timepoint
Before taking the drug and: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 24, 48 and 72 hours after taking the drug
Method of measurement
Liquid chromatography-mass spectrometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: includes the oral consumption of a 5 mg aripiprazole tablet manufactured by Kimidarou Pharmaceutical Company of Iran on 24 healthy fasting volunteers. 5 ml of blood at time intervals before taking the drug and: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 24, 48 and 72 hours after taking the drug It is taken from volunteers. The cross-over study consists of two phases (oral administration of a 5 mg aripiprazole tablet in each study and 2 times in total) with a seven-week washout period (when the drug is completely out of your blood). Aripiprazole plasma concentration is determined by liquid chromatography-mass spectrometry method. The analysis of the results will be based on ANOVA and t-test statistical methods.
Category
Other
2
Description
Intervention group 2: includes the oral consumption of a 5 mg aripiprazole tablet manufactured by Otsuka Pharmaceutical Netherlands B.V. in the United Kingdom on 24 fasting healthy volunteers. 5 ml of blood at time intervals before taking the drug and: 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 24, 48 and 72 hours after taking the drug It is taken from volunteers. The cross-over study consists of two phases (oral administration of a 5 mg aripiprazole tablet in each study and 2 times in total) with a seven-week washout period (when the drug is completely out of your blood). Aripiprazole plasma concentration is determined by liquid chromatography-mass spectrometry method. The analysis of the results will be based on ANOVA and t-test statistical methods.
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 Bouevard
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
Chemidarou Pharmaceutical Company
Full name of responsible person
Mojgan Aghajani
Street address
after Saipa repair shop, Kilometer 3,Tehran-Abali road, Sorkhe Hesar, District 13
City
Tehran
Province
Tehran
Postal code
1746773611
Phone
+98 21 7733 0291
Email
office@chemidarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chemidarou 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 Squar, 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 Square, 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