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In- Vivo Bioequivalence study of Linalidomide capsule 25 mg (Actero Pharma., Iran) with brand drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb,UK) in Iranian healthy volunteers.

Protocol summary

Study aim
In- Vivo Bioequivalence study of Linalidomide capsule 25 mg Actero Pharma. with brand drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb,UK) in Iranian healthy volunteers.
Design
In-vivo bioequivalence study of Linalidomide 25 mg hard gelatin capsules (Actero Middle East, Iran) with reference drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb, UK). The single blind, Cross-over, two period, two sequences (Intervention and control) and randomized study with one week wash-out period.
Settings and conduct
study background is biopharmacy and pharmcokinetics. Place of study is Simin Baspar Tayf-Gostar Inc, Tabriz. Study blinding will done by taking the test and reference drugs out of their original packaging and put them in the similar packaging. The volunteers will not be informed about the type of received drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-55 years, body mass index (BMI) in the range of 18-28. Exclusion criteria: History of heart, kidney and liver disease, Pregnancy, Drug addiction, Smoking
Intervention groups
Intervention group: Single dose of Linalidomide capsules 25 mg Actro Pharma. Control group: Single dose of brand drugs (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb, UK). The study is designed as cross-over in two 72-hours period with one week wash out time. The interfering factors in the study including: inter-subject variability of volunteers, type of drug and healthy condition of volunteers.
Main outcome variables
Plasma drug concentration

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200105046010N53
Registration date: 2022-01-23, 1400/11/03
Registration timing: registered_while_recruiting

Last update: 2022-01-23, 1400/11/03
Update count: 0
Registration date
2022-01-23, 1400/11/03
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
2021-12-01, 1400/09/10
Expected recruitment end date
2022-07-01, 1401/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
In- Vivo Bioequivalence study of Linalidomide capsule 25 mg (Actero Pharma., Iran) with brand drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb,UK) in Iranian healthy volunteers.
Public title
In-vivo Bioequivalence Test of Linalidomide capsules with brand drug (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb, UK)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
General health Body mass index between18-28 Informed consent Being at the age of 18-55 years old
Exclusion criteria:
Smoking A history of cardiovascular disease A history of liver & kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity to the drug
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
For this purpose, A 24- persons group will be selected and divided to two 12-persons groups randomly. The names of all volunteers will be written on paper pieces and wrapped in aluminum foils. The first 12 papers will randomly be withdrawn from bottle will be selected as group A and others will be categorized in group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Information of the type of administered drugs will be kept hidden from volunteers. Test and Brand drugs are removed from their packaging by the executor and placed in similar cans. Volunteers will not be informed about receiving the brand or test drug.
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
Third floor; Central building; Tabriz University of Medical Sciences; Dneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-11-15, 1400/08/24
Ethics committee reference number
IR.TBZMED.REC.1400.732

Health conditions studied

1

Description of health condition studied
Bio equivalence test
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Plasma 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 after taking the tablet.
Method of measurement
High Performance Liquid Chromatography with tandem mass spectroscopy detector

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: One test capsule (Lenalidomide tablet 25 mg, Actro Pharma.) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and concentrations of the drug in Plasma samples will be measured by liquid chromatography with mass spectroscopy detector. The study is designed as cross-over, two 72-hours period with one week wash out time. The interfering factors in the study including: inter-subject variability of volunteers, type of drug and healthy condition of volunteers.
Category
Treatment - Other

2

Description
Control group: One Reference capsule (REVLIMID® 25 mg, Celgene, Bristol-Myers Squibb, UK) will be received. Blood samples will be taken for 72 hours at the mentioned times after drug administration and the concentration of Lenalidomide in plasma samples will be measured by liquid chromatography with mass spectroscopy detector. The study is designed as cross-over, two 72-hours period with one week wash out time. The interfering factors in the study including: inter-subject variability of volunteers, type of drug and healthy condition of volunteers.
Category
Treatment - 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 square
City
Tabriz
Province
East Azarbaijan
Postal code
5167874434
Phone
+98 41 3384 2724
Email
Shokri.j@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Actero middle east Pharm. Co.
Full name of responsible person
Sanaz Golbabaei
Street address
Tehran
City
No 58, 6th St, Balouchestan St, Tehran, Iran
Province
Tehran
Postal code
1446863914
Phone
+98 21 4431 9003
Email
info@actoverco.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Actero middle east Pharm. 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
Javad Shokri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Sciences, Daneshgah
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, Tabriz University of Medical Sciences, Daneshgah
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, Tabriz University of Medical Sciences, Daneshgah Street
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
All information and data of the study will remain secured based on the agreement established between researcher and drug producer.
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
The access to data will be possible after finishing of project (almost 6 months after receiving of 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
By email to the project manager (shokri.j@gmail.com)
What processes are involved for a request to access data/document
These information are confidential and be under disposal of the project's contractor. Upon request, the information will be accessed to the applicant by the Executor's email after receiving contractor's consent.
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