In- Vivo Bioequivalence study of Levetiracetam tablet 1000mg Cobel Darou (LEVEBEL 1000mg) with brand drugs (KEPPRA 1000mg UCB Pharma, Belgium) in Iranian healthy volunteers
In- Vivo Bioequivalence study of Levetiracetam tablet 1000mg Cobel Darou (LEVEBEL 1000mg) with brand drugs (KEPPRA 1000mg UCB Pharma, Belgium) in Iranian healthy volunteers.
Design
Single dose, randomized, two sequences, two period, crossover with a washout period
Settings and conduct
This project will designed as fasting condition in two separated 24 hour time with a week washout time. Each sequences will receive the test or drugs in the first period and crossed over in the second time. The washout time will be determined based on the biological half life of the drug. Sampling process will be perform under supervision of a general physition. The blood will collected in the special blood tubes and plasma were separated by centrifuge and will analyze by HPLC.
Participants/Inclusion and exclusion criteria
24 participants will be selected from non-smoking, not-pregnant people with no history of heart, kidney, and liver disease or disfunctions with both sex (male and female). The ages and BMIs of participant should be in the range of 18-60 and18-25 respectively.
Intervention groups
.Both groups received in cross-over design medication and testing at two different cross-sections and Therefore, the test results are independent of individual differences and it will only show the difference in the formulation of the two drugs.
Main outcome variables
Cmax, Tmax, T1/2, Ke (Elemination)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200105046010N1
Registration date:2020-04-12, 1399/01/24
Registration timing:registered_while_recruiting
Last update:2020-04-12, 1399/01/24
Update count:0
Registration date
2020-04-12, 1399/01/24
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
2020-02-19, 1398/11/30
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Levetiracetam tablet 1000mg Cobel Darou (LEVEBEL 1000mg) with brand drugs (KEPPRA 1000mg UCB Pharma, Belgium) in Iranian healthy volunteers
Public title
Levetiracetam tablet 1000mg (LEVEBEL 1000mg, Cobel Darou) In- Vivo Bioequivalence study in Iranian healthy volunteers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health (liver & heart & kidney )
Body mass index (18-25)
Informed consent
Age (18-60 )
Exclusion criteria:
Smoking
A history of cardiovascular disease
A history of Liver & Kidney disease
Pregnancy
Alcohol & Drug addiction
Hypersensitivity
Age
From 18 years old to 55 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
Individuals are randomly selected with advertising 24 volunteers categorized in two sequences randomly.the type of drug (Sample and Brand drug) will prescribe with lottery.
Blinding (investigator's opinion)
Single blinded
Blinding description
Candidates are not aware of the test drug or brand name.
Placebo
Not used
Assignment
Crossover
Other design features
Two periode / Two sequence with a washout time
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences ethics committe
Street address
No. 48, Ferdows street, Ferdowsi Sq.
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
code: IR. TBZMED.REC.1398.1165
Health conditions studied
1
Description of health condition studied
in this study the bioequivalence of test and brand of levetiracetam will evaluated.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Drug analysis in plasma or whole blood
Timepoint
After blood sampling
Method of measurement
HPLC, LC-MS/MS or UPLC-MS/MS
Secondary outcomes
empty
Intervention groups
1
Description
Crossover study with two intervention groups. Intervention group A (Sequence 1, volunteers 1-12) and intervention group B (sequence 2, volunteers 13-24) without control group based on the guidelines of FDA for bioequivalence study. intervention parameters including: type & dose of the drug, type of dosage form, sampling intervals,sample preparation method, feeding or fasting conditions, analytical method and individual differences between subjects. single dose, randomized, double blind, two ways, two periods study.
Category
Other
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, Ferdos street
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Fax
+98 41 3384 2724
Email
shokri.j@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Cobel Darou Pharmaceutical Company
Full name of responsible person
Dr Sarfarzi R&D manager
Street address
Tehran, Argantin Sq, Alvand street, Corner of Cambys Alley
City
Tehran
Province
Tehran
Postal code
13897 - 76363
Phone
+98 21 8867 1230
Fax
+98 21 8867 1240
Email
info@cobeldarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Cobel Darou 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
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
Tabriz University of Medical Sciences, Faculty of Pharmacy
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
Pharmaceutical Sciences
Street address
Tabriz University Faculty of Pharmacy
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
Others
Street address
Tabriz University faculty of Pharmacy
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 data 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
Yes - There is 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 data request.