In- Vivo Bioequivalence study of Itraconazole Capsules 100mg Kimidarou in comparison with brand drugs SPRANOX® 100mg Cps, Janssen-Cilag Pharma. Belgium.
Design
Single dose Itraconazole Capsules 100mg Kimidarou
Settings and conduct
This study will be conducted in two-way, cross-over and fasting, and on two sets of healthy volunteers. The study will be conducted in two periods of twenty-four hours.The interval between these two periods, which is called the wash-out time, is determined by the half-life of the drug plasma, which according to scientific sources should be at least 5 to 7 half-life of the drug in the case of the drug under study. The plan will take a week to clean up the drug, given the biological half-life of the drugs in the drug form.In the first round, candidates are divided into two groups, and the first group receives a test tablet and the second group receives a similar tablet. Blood samples will taken by the volunteer by the technician immediately after taking the drug, and the preparation steps of the samples, including plasma separation and drug extraction, are performed to analyze the amount of drug
Participants/Inclusion and exclusion criteria
24 participants will be selected from non-smoking, non-pregnant people without history of heart, kidney and liver disease from both sex (male & female). The ages and BMIs of participant should be in the range of 18-55 and 18-28 respectively.
Intervention groups
Intervention group: single dose Itraconazole Capsules 100mg Kimidarou and control group single dose drugs SPRANOX® 100mg Cps, Janssen-Cilag Pharma Belgium.
Main outcome variables
Determination of blood drug concentration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N15
Registration date:2020-11-03, 1399/08/13
Registration timing:prospective
Last update:2020-11-03, 1399/08/13
Update count:0
Registration date
2020-11-03, 1399/08/13
Registrant information
Name
Javad Shokri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3661 4125
Email address
shokri.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-07-11, 1400/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pharmacokinetic assessments of Itraconazole capsules in comparison with brand drug SPRANOX
Public title
Itraconazole capsules in-vivo bioequivalence in healthy volunteers iranian
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health (liver, heart, kidney)
Body Mass Index (BMI) between 18-28
Informed consent
Age between 18-28
Both male and female
Exclusion criteria:
Smoking
Pregnancy
Alcohol & Drug addiction
Hypersensitivity to the drug
Age
From 18 years old to 60 years old
Gender
Both
Phase
Bioequivalence
Groups that have been masked
Participant
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation law is the simplest method of finite randomization.This method represents a large block for the entire sample size; this means that a balance in the number of people assigned to each group will be achieved at the end of the study. For this purpose, first determine a total sample size (24 people), then write the names of the people on paper, and after folding in aluminum foil, pour it into a glass, and then randomly remove the papers and open the first 12 people in group A and The rest are selected as group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Candidates are not aware of the test drug or brand name. In a one-blind study, information that could distort the test result is hidden from the candidates, but the person in charge of the test is aware of it. Itraconazole and SPRANOX® are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Third floor, Central Bulding of Tabriz University of Medical Sciences, Daneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-09-27, 1399/07/06
Ethics committee reference number
IR.TBZMED.REC.1399.667
Health conditions studied
1
Description of health condition studied
In this study, the disease is not examined. Subject bioequivalence test and reference Itraconazole Capsules studied.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Determination of blood drug concentration.
Timepoint
Sampling times in this study will be 0, 1, 2, 2:30, 3, 3:20, 3:40, 4, 4:20, 4: 40, 5, 6, 8, 10, 12, 24, 48, 72 hours.
Method of measurement
Liquid Chromatography with tandem mass spectroscopy detector
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single dose of Itraconazole Capsules 100 mg Kimidarou Company as a test product.
Category
Treatment - Drugs
2
Description
Control group: Single dose of Itraconazole Capsules with brand drugs SPRANOX® 100mg Cps, Janssen-Cilag Pharma. Belgium.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Simin Baspar Teyf Gostar Company
Full name of responsible person
Javad Shokri
Street address
No.48, Ferdowsi street, Ferdowsi Sq.
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Fax
Email
Shokri.j@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chemidarou company
Full name of responsible person
Shima Pakdaman
Street address
3rd km of Tehran-Abali road
City
Tehran
Province
Tehran
Postal code
1746773611
Phone
+98 21 7733 0291
Email
chemidarou@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kimidarou 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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University of Medical Sciences, Daneshgah Street,Tabriz East Azerbayjan
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University of Medical Sciences, Daneshgah Street,Tabriz East Azerbayjan
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, University of Medical Sciences, Daneshgah Street,Tabriz East Azerbayjan
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3334 8489
Email
Shokri.j@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
These date are as secure between researcher and related industries.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only protocol and methods of study are sharable.
When the data will become available and for how long
After finishing of the protocol (Probably 6 months receiving IRCT code)
To whom data/document is available
Pharmaceutical and medical sciences researchers.
Under which criteria data/document could be used
Projects information's for any publications is not allowed.
From where data/document is obtainable
Contact with E-mail of the main researcher.
What processes are involved for a request to access data/document
Personal and academic details and the aim of the request.